HIV/AIDS Prevention

1. Introduction

Prevention programmes remain the cornerstone of worldwide efforts to fight HIV/AIDS.

Because HIV/AIDS has no vaccine or cure thus far, most energy in South Africa has been put into developing prevention programmes that attempt to stop people contracting HIV/AIDS. The success of these programmes has been mixed. Although the incidence of infection appears to be stabilising in South Africa, this may be more to do with the nature of the HIV epidemic than the efforts of prevention programmes.

Generally, HIV prevention requires a multi-faceted approach. HIV prevention measures begin with the individual and his/her lifestyle choices, including abstinence, faithfulness and safe sex, and protecting others if already HIV infected. But communities also play an active part in HIV prevention, including the destigmatisation of the virus and support of those that are HIV-positive. Finally, the health care system and legal framework need to aid those who are at risk of HIV-infection, or infecting others.

2. Condoms

2.1 Overview

The use of a condom is one of the most effective ways of preventing HIV infection, and other sexually transmitted diseases, by creating a barrier that prevents the transfer of bodily fluids. A condom is also commonly used to prevent contraception.

Definitions (American Heritage Dictionary)

  • A male condom is a flexible latex or rubber sheath, designed to cover the penis during sexual intercourse.
  • A female condom is a loose-fitting polyurethane sheath that is closed at one end and inserted into the vagina before sexual intercourse.

 

If a condom is not used properly, HIV prevention is compromised considerably. However, even in cases of irregular usage which causes breakages and slippages, the risk of HIV infection, sexually transmitted infection and pregnancy is far lower than if the condom is not used at all.

2.2 History of Condoms

Condoms have been traced back to ancient Egypt where a linen sheath was used as a protection against disease.

The first published text on the condom was authored by Italian atomist Gabrielle Fallopius in the 1500s. He claimed his invention, a medicated linen sheath, prevented syphilis — a disease that was epidemic in Europe at the time.

But the earliest recorded use of the word condom (or "condum") only came in a 1706 poem, a reference some suggest to the doctor of Charles II, Dr Condom, who might have wanted to help the king prevent the conception of more illegitimate children.

By the mid 1800s, the invention of vulcanised rubber — a process where rubber is heated and elasticised — enabled the production of a cheap and more effective mass-produced condom.

The next major technical advance occurred in the 1930s when condoms were created with liquid latex.

Condoms were first used as protection against sexually transmitted diseases, then grew to prominence as a contraceptive device. By the 1960s, the use of the condom declined as "the pill", the coil and sterilisation became more popular. But condom use and access has dramatically increased since the advent of HIV/AIDS.

2.3 The Female Condom

The female condom was developed in the late 1980s.

The female condom is a polyurethane sheath that lines the vagina to create a barrier against the exchange of body fluids. It comprises of an inner and outer ring. The inner ring at the closed end is used for insertion and helps to maintain the device at upper end of the vagina. The larger outer ring remains outside the vagina and anchors the condom so that the sheath covers the external genitalia as well as the base of the penis during intercourse.

In 1998, the female condom was introduced as a South African dual protection option against unintended pregnancies and sexually transmitted infections, including HIV/AIDS.

Female condoms are more expensive than male condoms (e.g. The Global Public Sector Price agreement between UNAIDS and FHI is about $0.58 per Female Condom), but are still viewed as a cost-effective contraceptive especially amongst high-risk groups such as sex-workers.

Key Research

A 2000 study by the Reproductive Health Research Unit on the introduction and use of the female condom in South Africa indicated that, of the females that received female condoms,

  • 44% reported continued use after initial experimentation
  • the biggest factor in non-use was partners objecting to it
  • A small minority of respondents found it difficult to insert the device, and reported slippage and noise.
  • 90% reported using protection more often after the female condom was made available to them, with 44% of female condom users reported also using male condoms

The study also found that "many women" found the female condom to be empowering, primarily because it allowed them protection in situations where the male partner refuses to wear a male condom. (The female condom can be inserted up to eight hours before intercourse.)

The study found that supply and distribution of female condoms was sometimes haphazard and unpredictable and that health providers lacked time to counsel patients on proper use.

FHI Research Briefs on the Female Condom — - No. 6: Female Condom Introduction in South Africa.
Diagram: WHO/UNAIDS

Safe sex without the squeak

DEC 5, 2005 — With a rustle and a softer squeak, an undercover agent against the HIV epidemic is being relaunched around the world. ...

... Recently an as-yet unpublished study in South Africa found that 80% of men liked the female condom, and the same percentage of women agreed. The men commented that female condoms did not reduce sensation as much as the male condom, and were preferable and less constricting. There are anecdotal reports that men don't always know that a Femidom is being used. Read more.

Also read: Unexpected thrills.

2.4 Condom Reliability

Fast Facts

100% Efficacy of condoms in ideal conditions

85% Effectiveness of condoms in actual conditions

Source: US National Institute of Allergy and Infectious Diseases, 2000

Various terms are used to describe the usefulness of condoms in preventing HIV/AIDS.

The National Institute of Allergy and Infectious Diseases (NIAID) and other US federal agencies reviewed studies on condom effectiveness in 2000 (Scientific Evidence on Condom Effectiveness for Sexually Transmitted Disease (STD) Prevention 1.21MB), and concluded:

The Centers for Disease Control & Prevention (CDC) has concluded that: "Latex condoms, when used consistently and correctly, are highly effective in preventing the sexual transmission of HIV, the virus that causes AIDS." (CDC Factsheet)

The female condom is estimated to be 95% effective when used consistently and correctly.

2.5 Distribution

2.6 Access and Use of Condoms

Fast Facts: Condom use

85%of commuters have easy access to condoms

45%of commuters used a condom the last time they had sex

Source: Cadre, 2002

In South Africa

More South Africans use condoms than don't whenever they have sex, research suggests, though the proportion of sexually active people who do not use condoms remains high.

Key Research

2.7 Quality Standards

Condom quality in South Africa is tested by the South African Bureau of Standards ( SANS 4074 / 2003 ). All condoms supplied by the government are SABS-approved and comply with World Health Organisation standards.

This was not always the case. In December 1998, the New York Times reported that 4-million Kenzo brand condoms, not tested before distribution, were recalled by the SA Department of Health after sex workers complained about defects.

In 1999, thousands government issued condoms were found to be perforated by staples used to attach anti-AIDS pamphlets. (read Ministry of Health press release)

Faulty Condoms Thwart AIDS Fight in Africa

Dec 27, 1998 — Out of the depths of the AIDS epidemic sweeping Africa, an ugly truth is emerging: Some condom makers have been dumping their substandard wares here and Africans have been risking their lives on brittle, leaky or ill-fitting condoms.

... Hundreds of millions of condoms are handed out free on this continent each year, paid for — - and tested — - by international aid agencies.

Even now, though, more than 4-million Kenzo brand condoms from Polo Latex Co. of Calcutta are on their way back to India. They were not tested before distribution, and complaints from Cape Town prostitutes flooded in to SWEAT, the Sex Workers Education and Advocacy Task Force, a community aid agency, which had handed thousands out free.

... When they were checked, the results were shocking: As many as 48 out of 200 in some test batches broke. Read more

Follow-up:

The government responded the next day, saying new tender specifications along internationally accepted principles for the next year would "reduce the possibility of faulty condoms being distributed".

3. Education

3.1 Overview of HIV-AIDS Education in SA

Anton Hamel/Perinatal HIV Research Unit (PHRU)

The SA National Department of Health's education strategy follows an "ABC" preventative strategy (Abstain, Be faithful, Condomise).

While condom use is largely credited as the most important preventative measure, education programmes have been implemented to advocate changes in all three areas.

Major educational campaigns have included:

The Beyond Awareness Campaign

The "Beyond Awareness" campaign (1998-2000) targeted young people through a multi-media campaign that communicated key messages around the HIV/AIDS epidemic. The campaign promoted symbols like the red ribbon logo and the AIDS toll-free helpline phone number. It also provided leaflets, posters, booklets and other "tools for action" that supported governmental, non-governmental and community-based organisation efforts to engage with the epidemic and promoted the free National AIDS helpline, established in 1992. The campaign ran on an annual budget of around R13-million.

Soul City

The Soul City project uses television and radio dramas and print material, to promote public awareness around health issues, including HIV/AIDS. Each series deals with three or four key health or social issues. HIV/AIDS has been a key issue in each series since it began. Each series includes 13 prime-time television episodes, 45 15-minute radio dramas, three widely distributed colour booklets, an advertising campaign and an advocacy campaign, according to Soul City.


loveLife

loveLife

The loveLife campaign was launched in 1999. The campaign aims to "brand" safe sexual behaviour as part of popular youth culture and so reduce the HIV-infection rate among young South Africans. LoveLife strives to promote communication about sex and encourage informed decision-making. The programme includes nationwide media strategies including a prominent billboard campaign that aims to promote sexual responsibility. LoveLife also offers service and support programmes that assist youth centres and public clinics. Lovelife continually monitors and evaluates the campaign's effectiveness. The campaign's major funders are the Henry J. Kaiser Family Foundation and the Bill and Melinda Gates Foundation. The SA government provides approximately 12% of loveLife's current annual budget of around $20-million. (Read more here)

Khomanani — Caring Together

The SA government's HIV/AIDS communication campaign, "Khomanani — Caring Together", aims to "move the nation to act by informing, inspiring and empowering individuals, civil society, business and government, through the effective and efficient use of media". The campaign focuses on youth prevention, support for vulnerable children, living positively with HIV, effective STI treatment, TB control and supporting health workers.

3.2 Criticism of SA HIV/AIDS Education

loveLife

Lovelife's use of sexual imagery, its sometimes obscure messaging and the large budget it controls has been criticised by some NGOs, religious groups and media critics.

The Centre for AIDS Development, Research and Evaluation (Cadre) in South Africa questioned the effectiveness of the loveLife campaign in 2002, including:

An updated critique of loveLife's use of research in their publicity material was published by Cadre in 2003. (Re-appraising youth prevention in South Africa: The case of loveLife).

In late 2005, the Global Fund decided not to award a proposed $56-million grant to the Lovelife programme. Lovelife was "deemed to not have sufficiently addressed weaknesses in its implementation which originally led the Global Fund Secretariat to recommend no continued funding after two years".

Global Fund spokesperson, Jon Liden alluded to other shortcomings. "The issue was the programme's ability to reduce HIV infection among young people," Liden told Business Day. Lovelife CEO, David Harrison, argued that abstinence-only Christian fundamentalists in Washington conspired against loveLife's more progressive programme. "loveLife is a victim of international politics … squeezed between the ideological right and progressives," he told Business Day.

In 2003, Chris Barron wrote an incisive piece for The Media, which questioned the effectiveness of the loveLife campaign and alleged that advertising contracts prevented criticism of the campaign by some media groups. (see full text).

LoveLife: Buying the Silence?

Nov 1, 2003 – The most extraordinary media campaign in South African history has been the multi-million rand billboard blitz mounted by the world's most cash flush AIDS organisation, loveLife.

LoveLife insists that the object of the billboards, on which it lavishes R13-million a year (most AIDS NGOs consider themselves lucky if they get R200,000 a year in toto), is to reduce the HIV infection rate among the youth by getting them to change their sexual behaviour.

... NGOs and church groups working at the sharp end of the epidemic for a fraction of what loveLife spend on their billboards confess that they can't for the life of them see how flashy posters of good-looking young things in seductive poses and various states of undress are supposed to reduce HIV infection.

... In return for R20-million a year in advertising the Sunday Times (which publishes its Scamto publication), the Independent Group (thethaNathi) and the SABC have signed contracts prohibiting them from publishing material that will harm the loveLife image.

... The only (superficially) critical pieces about loveLife have been in Noseweek, Fair Lady magazine and The Citizen. ... Read more

 

3.3 Studies on HIV-AIDS Education

Key Research

A 2004 study,HIV and Sexual Behaviour Among Young South Africans: A national survey of 15-24 year olds (1MB), conducted by the Reproductive Health Research Unit in association with loveLife reported that:

"The survey shows that more than two thirds of youth report changing their sexual behaviour because of awareness about HIV/AIDS, and substantial increase in reported condom usage at last sex."

The survey found that among 15-24 year olds:

  • 94% know that there are ways to avoid HIV infection
  • 63% reported they had changed their behaviour to avoid HIV
  • 77% reported that condoms could be used to prevent HIV
  • 52% reported using a condom at last sex
  • 85% reported having heard of or seen loveLife material
  • 44% reported having talked to their parents about HIV/AIDS
  • 20% reported having been tested for HIV

Every participant in the survey was also HIV-tested. The study found that among 15-24 year-olds, 10.2% are HIV-positive.

REPORTING TIP: It is important to note that the "self-reported" actions that a person tells a researcher might not reflect "actual" actions. In other words, what people say they do is not necessarily what they do. As a rule, always ensure that you indicate the limitations of the research you are quoting from.

The 2005 HIV Prevalence Incidence Behaviour and Communication Survey found varying levels of HIV/AIDS knowledge, with 12-14 year-olds and people aged over 50 most likely to be uninformed on fundamental HIV/AIDS concepts.

Knowledge area 12-14 15-24 25-49 50+
Say no or don't know when asked if it is possible to transmit HIV through unprotected vaginal sex 18.7% 6.1% 4.3% 11.2%
Say no or don't know that it is possible to transmit HIV from a mother to her unborn child 31.9% 18.4% 13.8% 23.5%
Say no or don't know that it is not possible to transmit HIV by touching someone who has HIV/AIDS 93.0% 95.6% 94.7% 93.1%
Agree or unsure there is cure for AIDS 24.3% 17.5% 21.1% 28.6%
Disagree or are unsure that HIV causes AIDS 20.8% 9.0% 12.6% 25.7%
Disagree or are unsure HIV infection is prevented by using condoms 18.1% 11.0% 10.8% 21.3%
Disagree or are unsure can reduce the risk of HIV by having fewer sexual partners 43.4% 32.8% 32.6% 35.0%
Source: Knowledge of HIV/AIDS by age group in South Africa. 2005 HIV Prevalence Incidence Behaviour and Communication Survey

The 2002 Nelson Mandela/HSRC Study of HIV/AIDS (1.1MB) (read summary) found "significant changes in sexual behaviour in South Africa over the past four years", when compared to the 1998 Demographic and Health Survey.

The study found that:

4. HIV/AIDS Vaccine

4.1 Overview

 

Vaccines have been used for over 200 years to prevent diseases like smallpox, measles and polio from spreading across populations.

Vaccines are not cures, but rather treatments that can prevent disease or infection. They are the only long-term solution to controlling a viral epidemic.

A vaccine, when administered to an individual, provokes an immune response in order to teach the body to recognise a particular disease-causing organism in the future. In this way the body is prepared to launch an effective attack against the particular organism, thereby preventing disease.

Currently, vaccine researchers are developing a preventative HIV vaccine that can teach the body's immune system to recognise and protect itself from HIV.

The HI virus usually attacks the important T-helper cell, which co-ordinates the immune system's response to infections. The ideal vaccine will produce antibodies that will neutralise the virus before it penetrates the immune cells, and stimulate an immune reaction inside the T-helper cell to defend itself against the virus.

At present, there is no HIV vaccine available to the public. It could take more than 10 years to develop the first publicly available vaccine.

We're running out of time

Jan 30, 2006 - ... Overcoming the biomedical obstacles to an AIDS vaccine is perhaps the toughest public-health test of our time. But a large part of the challenge thus far has been a matter of policy. Most of the expertise in developing vaccines is held by Big Pharma. Yet it's been difficult to convince the private sector to invest in vaccines—traditionally high-volume products that provide relatively low return on investment. Unlike a drug that patients may have to take for a lifetime, an effective vaccine is literally a "one shot" deal—there are virtually no repeat customers. ... Read more.

Berkley is president and CEO of the International Aids Vaccine Initiative.

4.2 Challenges in Developing an HIV/AIDS Vaccine

Scientists have determined that an ideal vaccine — single dose, low-cost, long-lived, stable, safe and effective — will be difficult to develop in the short to medium term. Scientists are therefore also considering partially effective vaccines that could still save millions of lives.

Challenges:

Phases of Vaccine Research

Phase Description Sample
Phase I Trials mainly measure the safety, side effects and early immune response to the test vaccine. Low risk HIV-negative adult volunteers are used. 12-18 months.
Phase II Controlled trials that test the above as well as the efficacy, dosage and routes of administration of the vaccine Between 200 and 500 HIV negative adult volunteers. Can last up to two years.
Phase III Trials are larger controlled trials that determine the effectiveness of the vaccine as well as the optimal dosage and schedule of the vaccine. Involves thousands of HIV-negative, usually high-risk volunteers. Usually lasts for three to four years.

4.3 International and South African Vaccine Initiatives

There are multiple international efforts to develop an HIV vaccine. Over 60 phase I/II trials of 30 candidate vaccines have been conducted worldwide, according to the National Institutes of Health in 2000. A full database of HIV/AIDS vaccines currently being researched is accessible from the International AIDS Vaccine Initiative (IAVI) website.

A Phase III trial is currently being conducted in Thailand by developers Aventis and Vaxgen. The trial involves 16,000 participants and is the most advanced trial at this stage. A phase IIb trial by Merck is the next most advanced, with proposed trial sites in the USA, Dominican Republic, Haiti, Peru, Canada and Australia (source).

Only one potential HIV/AIDS vaccine has gone through all three trial phases but it was found to be ineffective in preventing transmission by sexual intercourse or injecting drug use (source).

The South African AIDS Vaccine Initiative (SAAVI) was established in 1999 to co-ordinate the research, development and testing of an HIV/AIDS vaccine for South Africa. SAAVI contributes to international research with its focus on HIV-1 subtype C, which is the most prevalent subtype in Southern Africa, accounting for over 90% of new infections.

The University of Cape Town and the University of Stellenbosch are developing HIV/AIDS vaccines for HIV-1 subtype C.

There are also a number of Phase I clinical trials in South Africa:

Start Date Trial No. Vaccine Participating agencies and manufacturers Objective

October 2004

HVTN 059

AVX101 (VEE)

NIAID, AlphaVax

Evaluation of the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana (more info).

September 2004

HVTN 050/Merck 018

MRKAd5 HIV-1

NIAID; Merck

A worldwide Phase I dose-escalating study of the safety, tolerability and immunogenicity of a three dose regimen of the MRK Adenavirus Serotype 5 HIV-1 GAG (MRKA 5 HIV-1 Grag) vaccine in healthy adults (more info).

November 2003

IAVI 011

MVA-HIVA

IAVI, SAAVI; IDT

Evaluation of the safety and immunogenicity of modified Vaccinia virus Ankara vaccine containing the Clade A HIV-1 gag gene (more info).

July 2003

HVTN 040

AVX101 VEE

NIAID; SAAVI; AlphaVAX

A Phase I safety and immunogenicity trial of an Alphavirus Replicon HIV subtype C Gag Vaccine (AVX101, Alphavax Inc.) (more info).

5. Prevention of Mother-to-Child Transmission (PMTCT)

5.1 Overview

A woman who is HIV-positive can pass on HIV to her baby during pregnancy, during childbirth and during breastfeeding. In most cases, the virus is transmitted just before, during, or immediately after labour. Only a small percentage of children get HIV while still in the womb as the mother's blood and foetus' blood usually do not mix in the womb.

Unicef estimates that in the absence of preventative interventions, the probability that an HIV-positive woman's baby will become infected is approximately 25% — 35% (i.e. approximately one in three children born to HIV-infected mothers). This risk factor is considerably higher than any other potential exposure to HIV, except through blood transfusion (90%).

In South Africa, without any interventions, an estimated 77,000 infants are infected with HIV per year. With interventions in 90% of cases, this figure would be reduced to about 28,000 infants infected with HIV per year (Heywood, 2003).

The two major factors for the transmission of the virus from mother to child are:

1. Viral Load. The viral load (i.e. the number of HIV particles in the blood) is the most important factor in the transmission of HIV from mother to child. The higher the mother's viral load, the more chance there is that the infant will be HIV infected. A short course of antiretroviral drugs can reduce the viral load and increase the chances of non-transmission.

2. Breastfeeding. Mothers can pass the virus to their children through their breastmilk, which is often HIV infected. Breastfeeding increases the risk of mother-to-child transmission by 10-15%, according to UNAIDS.

Antiretrovirals can be used to lower the viral load of the mother and thus reduce the risk of infecting the child. They can also be used as a post-exposure prophylaxis for an infant who has contracted the virus during pregnancy, during childbirth or, to a lesser extent, during breastfeeding.

The WHO recommends that HIV positive women who do not require ARV treatment yet (i.e. their CD4 count is above 200) but are pregnant should follow an ARV regimen "known to be safe and effective". Examples include combination and mono therapies with zidovudine (ZDV) , nevirapine (NVP) and lamivudine (3TC).

5.2 Research

Clinical studies have proven that the use of antiretrovirals significantly reduces the chance of transmission of HIV from mother to child. Below is an adapted WHO summary of PMTCT clinical trials:

Trial

Treatment plan

Percentage reduction in HIV transmission rate*

ZDV: Zidovudine 3TC: Lamivudine NVP: Nevirapine

Non-Breastfeeding populations

ACTG0760

ZDV administered from week 14, during labour and to infant for 6 weeks

68% (after 18 months)

'Thai short-course'

ZDV administered from week 36 and during labour.

50% (after 6 months)

     

Breastfeeding populations

Regimen started during pregnancy:

CDC, W Africa

ZDV administered from week 36 and during labour

37% (after 6 months)

PETRA Arm A

ZDV and 3TC administered from week 36, during labour and to infant and mother after labour for one week.

54% (after 6 weeks)

Regimen started during labour:

PETRA Arm B

ZDV and 3TC administered during labour and to infant and mother after labour for one week

39% (after 6 weeks)

HIVNET 012

NVP administered during labour. Infant receives single dose after labour.

42% (after 12 months)

SAINT

NVP administered during labour. Infant and mother receive single dose after labour.

Transmission rate 13% (after eight weeks)

     

* Percentage reduction in HIV transmission rate in active arm compared with placebo, except for NVP which was compared in HIVNET012 with a probably ineffective regimen consisting of intrapartum ZDV for the mother and one week post-partum for the infant

Adapted from: WHO, 2001. Prevention of Mother-to-Child Transmission of HIV: Selection and Use of Nevirapine (Technical Notes). (also in HTML)

5.3 Treatment in South Africa

Drug Regimen

HIV-positive pregnant women in South Africa are generally prescribed single-dose nevirapine in public health hospitals and clinics. However, in the Western Cape, a more effective regimen of AZT and nevirapine is administered, according to the TAC.

Although other regimens have proven more successful in preventing mother-to-child transmissions of the virus, they are not yet available in the wider public setting in South Africa. Reasons usually cited for this are affordability and safety and efficacy in a breastfeeding population.

The 2004 WHO PMTCT guidelines acknowledge single-dose nevirapine as the simplest regimen to deliver, especially in countries with poor health infrastructure. The guidelines however, recommend that "that programmes consider introducing more complex ARV regimens where possible". There are also concerns over the toxicity and viral resistance which can accompany nevirapine treatment.

Treatment Policy

Anton Hamel/Perinatal HIV Research Unit (PHRU)

The SA National Department of Health recommends that all pregnant women:

5.4 Side Effects and Toxicity

All antiretroviral drugs have known toxicities and form part of a cost-benefit equation that health practitioners employ when placing a patient on antiretroviral treatment.

Nevirapine

Although long-term use of nevirapine has been linked to liver toxicity (which can lead to liver failure and death), the drug still remains an "important part of an HIV treatment regimen" according to the US Food and Drug Administration. Single-dose use which is used in the prevention of mother-to-child transmission has not been linked to liver damage in either the mother or the child.

However, some studies have indicated that single-dose nevirapine can result in viral resistance that can complicate successful antiretroviral therapy for the mother later ( 2004 WHO PMTCT guidelines).

5.5 Infant Feeding

Under the present socio-economic circumstances in South Africa, there isn't one single feeding method for all HIV-positive women that can be recommended. Choices around infant feeding involve risk assessment. Hence all HIV-positive women should receive appropriate, high quality counselling and information on one of the following infant feeding options:

Exclusive breast feeding

John Hodgkiss/Perinatal HIV Research Unit (PHRU)

Breastfeeding can protect from many illnesses in the first few months of life, including diarrhoea, respiratory and other infections, provides complete nutrition, immune protection and stimulates growth and development in the infant. However, these benefits must be weighed against the risk of transmitting the HI virus to the infant through breast milk. Current recommendations include exclusive breast feeding, that is, the infant only receives breast milk, for the first four months of life, followed by abrupt weaning and two months of formula feeding, provided free in the public health setting.

Exclusive breast feeding can be difficult for women to implement. In many cases, the mother is not the only care giver and she cannot prevent other care givers from giving the infant other substances, such as juice, water or porridge. Traditional practices can inhibit exclusive breast feeding, for example, stomach cleansing, where traditional medicine is administered to the infant, but needs to be administered in conjunction with soft porridge as it cannot be taken without food. This can lead to mixed feeding.

Formula feeding

Currently the PMTCT programme in South Africa offers free formula milk for a period of six months to HIV positive women who choose not to breast feed. The WHO has recommended that bottle feeding should only be encouraged in HIV infected women if it is safe, feasible, acceptable, accessible and sustainable, but that if any of these conditions are not met, exclusive breastfeeding should be promoted. For example, women should have access to electricity, clean water, preferably financial resources such as transport money to and from the clinic to collect formula, the ability to buy a tin in an emergency and preferably support from the family, as bottle feeding is hindered by social pressure and stigma.

Feeding choices — which is the best one?

 

Breastfeed

Unsure

Formula Feed

Water Supply

River, stream, pond, well, borehole

Public Tap

Piped water at home

Sanitation

None, pit latrine

VIP toilet

Waterborne sewage

Income

Irregular income

 

R200 available every month for 1 year

Preparation and fuel

Unable to boil water and utensils every feed

 

Able to boil water and utensils every feed

Night feeds

Breastfeeds

Other family members can look after the baby at night

Formula feeds only

Family and community

Breastfeeding expected. Family unaware of HIV status

Family supportive of whatever mother decides

Family aware of HIV status and willing to help with feeding

Storage

No fridge available, irregular electricity

Access to fridge with regular electricity; Fridge not at home

Fridge at home with regular electricity

From KwaZulu-Natal infant feeding assessment guide. Source: Doherty, T et al. (2003). An evaluation of the Prevention of Mother-to-Child Transmission (PMTCT) of HIV initiative in South Africa : Lessons and Key Recommendations. Durban : Health Systems Trust.

Factors that hamper formula feeding

Poor infant feeding counselling for HIV-positive pregnant women

Historically training of counsellors has focused on Voluntary Counselling and Testing and not given due weight to infant feeding options. Thus, in many health settings women are not adequately counselled on infant feeding choices. Preferably counselling on infant feeding choices should not be conducted in post-test counselling, but in follow-up counselling sessions and PMTCT support groups.

The stigma associated with the free distribution of formula milk from clinics

Studies show that the stigma associated with the orange and white tin of the government-issue Pelagron is very high — often referred to as "AIDS milk" or "that orange tin". Women often adopt creative strategies to overcome this stigma, such as bringing their own tins to the clinic and transferring the formula into their own tins on site, before leaving (Ridgard 2005, Garson 2005).

There is a large amount of stigma associated with bottle feeding, as it is often seen as the marker of HIV/AIDS. Women also adopt creative strategies here, telling family members that they are unable to feed because they have breast cancer, cracked or infected nipples or that they have been instructed by a health care worker not to breast feed (Garson 2005).

The unreliable supply of formula to facilities, particularly feeder clinics

Studies have shown that often there is an unreliable supply of formula milk to facilities and there is poor distribution of formula to outlying clinics. This can inadvertently encourage mixed feeding, as women often may not have money to buy an emergency supply or inadequate dilution of the formula, which can lead to malnutrition and illness in the infant.

Mixed feeding

Mixed feeding occurs when an infant is breast fed as well as is given others substances, such as water, fruit juices, formula milk and soft porridge. Mixed feeding is discouraged because it puts the infant at a much greater risk of contacting HIV through the breast milk than exclusive breast feeding or formula feeding. This is because substances other than breast milk can rupture the ? as well as the stomach lining, making the transmission of HIV from the breast milk into the bloodstream of the infant relatively easy. Exclusive breast feeding does not run the same risk as an infant's body is designed to receive breast milk and it may not rupture the stomach lining, therefore making it difficult for the HIV to enter the blood stream.

Source: Doherty, T et al. (2003). An evaluation of the Prevention of Mother-to-Child Transmission (PMTCT) of HIV initiative in South Africa : Lessons and Key Recommendations. Durban : Health Systems Trust.

5.6 History of the Prevention of Mother-to-Child Transmission in South Africa

History of PMTCT treatment in South Africa

Period Action

1997+

Organisations including the AIDS Law Project (ALP), the AIDS Consortium and the Perinatal HIV Research Unit begin lobbying government to develop policy and implement a programme to prevent MTCT. The lobby is based on the 1994 National AIDS plan that refers to "steps to be taken to prevent peri-natal transmission of HIV". (Heywood, 2003)

1998

Gauteng Health Department responds to growing evidence that a short course of AZT brings significant reductions in MTCT by announcing trials of AZT at five pilot sites.

October 1999

SA government orders Medicines Control Council to review safety and toxicity of AZT for PMTCT and prohibits its use pending the outcome of the review.

Early 2000

MCC finds benefits of AZT outweigh risks but the government first rejects the report and sends it back to the MCC for further work, and later ignores it. (Heywood, 2003)

1998-2000

Results of studies, including HIVNET 12 and the South African Intrapartum Nevirapine Trial (SAINT), show single-dose nevirapine to be safe and effective. (For summary see: WHO PMTCT guidelines.)

August 2000

SA government announces nevirapine trials at 18 pilot sites across the country to "determine whether or not the exercise would be feasible, taking into account all the operational issues". Nevirapine is not made available outside of the pilot sites but private medical aid schemes offer the drug. (Heywood, 2003)

April, 2001

Nevirapine registered for use with MCC for PMTCT. The TAC later contested that minutes from MCC meetings showed that the drug's registration had been recommended by the MCC several months prior in November 2000, but had been held up on technical reasons including the wording of the drug package insert (Heywood, 2003).

August 21, 2001

The Treatment Action Campaign (TAC) files a constitutional court claim against the government, requesting that the government "be ordered to make Nevirapine available to pregnant women with HIV who give birth in the public health sector, and to their babies, where in the judgment of the attending medical practitioner or health professional this is medically indicated."

December 14, 2001

The High Court orders the government to allow Nevirapine to be prescribed to pregnant woman in South Africa where "medically indicated" and develop "an effective comprehensive national programme to prevent or reduce MTCT" by 31 March 2002, for further scrutiny by the Court." The government is later granted leave to appeal to the Constitutional Court. (see excerpt of judgement)

April 5, 2002

The Constitutional Court issues an interim order compelling government to provide nevirapine in institutions where it has the capacity to do so.

July 5, 2002

The Constitutional Court upholds the High Court decision and orders the government 'without delay' to make nevirapine available for the prevention of mother-to-child transmission at public hospitals and clinics.

Dec 13, 2004

An Associated Press story casts into doubt the results of the HIVNET 012 clinical trial of nevirapine when it is alleged that the trial had procedural flaws including the non-notification of some deaths of patients when on the program. (See NIH refutation of the AP story)

January 19, 2005

The US Food and Drug administration issues an advisory, reaffirming that nevirapine is an "important part of an HIV treatment regimen" but that the known toxicity of the drug should be considered when prescribed in long courses. However, the FDA maintains that evidence of major side-effects in single-dose courses of nevirapine has not been found.

November 2005

The UNAIDS Global Aids Epidemic Update reports that only 57% of HIV-positive pregnant women were being reached by the South African government's mother-to-child HIV transmission prevention programme. The report revealed that neighbouring countries, including Uganda, Zambia and Zimbabwe, were reaching almost 100% of HIV-positive pregnant woman (source).

Sources:
Cadre, 2004. Prevention of Mother-to-Child Transmission (PMTCT) in South Africa: Analysis of Calls to the National AIDS Helpline
Heywood, 2003. Preventing mother-to-child HIV transmission in South Africa: Background, strategies and outcomes of the Treatment Action Campaign case against the Minister of Health)

6. Post-Exposure Prophylaxis (PEP)

6.1 Overview

Viral Load versus Risk of Transmission

Studies have shown that the primary factor increasing the chance of HIV infection is the viral load in the blood of the infected person.

Other factors that can increase the chance of HIV infection include the presence of STIs and if the male is uncircumcised.

On average, the chance of HIV infection per single exposure during sexual intercourse is 0.11%. However, during the acute HIV infection phase (normally 3-8 weeks after infection), and when a patient has full-blown AIDS, the viral load increases to as much as one million copies/ml, greatly increasing the risk of infection.

Viral Load

Chance of transmission

References

<3,500 copies/ml

0.01% chance. (1 per 10,000 episodes of intercourse)

Gray, 2001

>50,000 copies/ml

0.51% chance. (5.1 per 1000 episodes of intercourse)

Gray, 2001

> 1-million copies/ml*

3.00% chance. (3 per 100 episodes of intercourse)

Chakraborty, 2001

* viral load in male semen. Studies have shown that the viral loads in blood and semen are comparable in the absence of STIs.

Source: Statistics adapted from: Estimating the Risk of Sexual HIV Transmission : Implications for the African Epidemic, Medscape, 2001.

When individuals are potentially exposed to HIV through sexual assault or occupational exposure, a programme of several antiretroviral drugs may be taken to prevent infection. PEP treatment needs to be commenced within 72 hours of the exposure, although there is evidence to suggest that the sooner the person commences treatment the greater the benefits.

Why take PEP?

It is generally accepted that the average risk of a person contracting HIV from:

However, factors such as the viral load of the infected blood, the amount of fluid involved and the nature of the injury (or sex) can affect the risk factor.

Despite the low risk of contraction through a single exposure, rape survivors and health workers do have a right to post-exposure prophylaxis.

PEP is not recommended for casual exposure to HIV/AIDS as it is not 100% effective, can have severe side effects and could encourage unsafe sexual behaviour.

Availability

PEP is theoretically available at all public sector hospitals and clinics. However, a 2004 report by Human Rights Watch found that "government failure to provide adequate information or training about PEP or clear messages in support of PEP significantly undermined access to this lifesaving service. Police, health professionals, and counselors working with rape survivors often lacked basic information about PEP, as did rape survivors themselves. As a result, many rape survivors did not get PEP simply because the various agencies charged with providing these services did not know that they existed." (Human Rights Watch, "Deadly Delay: South Africa's Efforts to Prevent HIV in Survivors of Sexual Violence")

6.2 Studies

Key Research

1. In a 1997 study of needlestick injuries to health-care workers, "the prompt initiation of zidovudine was associated with an 81% decrease in the risk for acquiring HIV" (CDC factsheet).

2. A 2001 study of homosexual and bisexual men who began taking PEP after a self-identified high-risk exposure found annual seroincidence (HIV-infection) was:

  • 3.9% amongst those who never used PEP
  • 1.1% amongst those who took PEP

3. In a study of rape survivors in South Africa: Of 480 initially seronegative survivors begun on zidovudine and lamivudine and followed up for at least six weeks only one woman seroconverted (who took medication 96 hours after the assault). (CDC factsheet)

6.3 In South Africa

In South Africa, individuals who have been raped or occupationally exposed to HIV have the right to obtain treatment. Most health care workers recommend PEP treatment whether the exposure was known to be HIV-positive or not.

In 2002, the South African Cabinet resolved to make post-exposure prophylaxis available to rape survivors.

In the Standard Treatment Guidelines and Essential Drugs List for South Africa (2003), recommendations are given for the use of PEP after exposure through sexual abuse and occupational injuries:

SA National Department of Health recommendations for Post-Exposure Prophylaxis

  1. Patients who have been potentially exposed to HIV 72 hours or more prior to consultation are not treated.
  2. An HIV test is compulsory. Patients who do not take an HIV test are not treated.
  3. Patients are put onto a short course of antiretrovirals during the testing phase.
  4. No PEP treatment is given to those already HIV+ as the short treatment might lead to viral resistance.
  5. A full 28-day course of PEP is administered. Normally zidovudine (AZT) and lamivudine (3TC) are administered, but the course can include a protease inhibitor if the injury is high risk.

Adapted from: Standard Treatment Guidelines and Essential Drugs List for South Africa, 2003.

7. Blood Screening

7.1 Overview

Fast Facts: Blood Safety

5-10% of all HIV infections world-wide acquired through transfusion of infected blood and blood products (estimate)

13-million units of the global blood supply not screened for HIV, annually (estimate)

Source: WHO, no date

Blood screening is very important as the risk of infection when exposed to HIV-infected blood is estimated at 90%.

An estimated 5-10% of all HIV infections world-wide are acquired through transfusion of infected blood and blood products, according to UNAIDS.

In South Africa, there is an approximate 0.04% HIV prevalence amongst people who donate blood regularly, according to the health ministry.

Every blood unit donated is tested for HIV, Hepatitis B and Hepatitis C.

The South African National Blood Service (SANBS) also profiles blood donors into risk categories using factors such as age, gender, geographic area, the donation history of the individual and, up until recently, racial group.

A new profiling system that excludes race as a factor is now being implemented with a focus on donation history of the individual as a primary risk indicator.

Despite profiling and testing, an average of two cases of HIV-infection through blood transfusion are reported per year in South Africa (source).

South Africa to end racial profiling of blood donors

Dec 4, 2004 — South Africa is to stop racially profiling blood donors after an outcry over the alleged rejection of blood from black donors because of the risk of HIV.

The health ministry and the South African National Blood Service agreed yesterday that a donor's colour should not be used to determine the risk of infected blood.

The row flared this week when the health minister, Manto Tshabalala-Msimang, discovered that alongside sexual practices and healthiness of lifestyle, the blood service used skin colour to evaluate safety for donation. "It smacks of racism," she said.

... Robert Crookes, medical director of the blood service, told the South African Press Association this was the "most logical, medical, ethical and legally defensible system available".

But yesterday the blood service appeared to row back after its chief executive, Anton Heyns, met health ministry officials in Johannesburg. ... Read more

Follow-up:

In mid-February 2005, the SANBS announced a new profiling system excluding race as a factor.

8. Prevention & Treatment of Sexually Transmitted Infections

8.1 Overview

The risk of HIV-infection increases during sexual intercourse if one or both sexual partners have another sexually transmitted infection (STIs). Another common phrase used for essentially the same condition is sexually transmitted disease or STD. Common STIs include syphilis, gonorrhea and genital herpes.

The risk of HIV infection increases for two main reasons:

Epidemiological studies have shown that people are 2-5 times more likely to contract HIV when other STIs are present.

The SA government's HIV/AIDS/STD strategic plan for South Africa (2000-2005) acknowledges the "compelling evidence of the importance of STDs as a major determinant of HIV transmission". There are approximately 11-million episodes of STIs annually in South Africa.

8.2 Prevention of STIs

The only way a person can 100% be sure they won't get an STI is if they abstain from sex.

People can reduce the risk of STI transmission by:

8.3 Treatment of STIs

If STIs are not treated, they can cause infertility in men and women, premature birth and birth defects.

Free STI treatment is available at most public health care providers, according to the South African health ministry.

Syndromic Management

In South Africa, "syndromic management" is often used to treat patients with STIs.

Syndromic management is the identification and treatment of a disease or infection based primarily on the symptoms that it presents.

Treating STDs Using The Syndromic Approach

Syndrome

Treat for

Men Urethral discharge

Gonorrhoea and Chlamydia

Women Lower abdominal pain

Gonorrhoea, Chlamydia and
other bacteria

Vaginal discharge

Cervicitis: Gonorrhoea and
Chlamydia Vaginitis:
Trichomoniasis and Candidiasis

Men or Women Genital Ulcers

Syphilis, Chancroid and Genital
Herpes

Source: WHO. Syndromic Case Management of Sexually Transmitted Diseases

8.4 Studies

Key Research

A 1999 review of scientific literature on the relationship between HIV and STIs (also referred to as STDs) found that:

  • increased risk estimates ranged from 2.0 to 23.5, with most clustering between 2 and 5
  • "available data leave little doubt that other STDs facilitate HIV transmission through direct, biological mechanisms and that early STD treatment should be part of a high quality, comprehensive HIV prevention strategy"

In a trial in Mwanza, Tanzania, six communities in the region were offered STI treatment over two years. Six other communities were monitored.

  • The incidence of HIV infection was reduced by 38% in the group which was offered STI treatment

Other studies in Rakai, Uganda showed no effect on HIV incidence with STI treatment. However, researchers suggested that the maturity of the epidemic and the role of untreatable STIs played a large part in the ineffectiveness of the STI treatment on HIV transmission rates.

9. Microbicides

9.1 Overview

Women are disproportionately affected by the HIV/AIDS epidemic in Africa. According to a UNAIDS Africa Factsheet (2005), in Sub-Saharan Africa 57% of those infected with the virus are female, or approximately 17-million women and girls. In Sub-Saharan Africa, 77% of the almost 9-million HIV-positive youth (15-25) are female.

The reasons for this are outlined in the gender factsheet. They include a biological vulnerability (heterosexual women can far more easily become infected through penetrative sex than heterosexual men) and a socio-economic vulnerability (women are often economically dependent on their husbands or partners). Women are often unable to negotiate condom use or other protective measures with their partners.

Microbicides, though not widely available yet, have the potential to provide a discreet method for women to protect themselves against HIV infection. Some microbicides can also be used as contraceptives.

9.2 Definition

A microbicide is an agent — in gel, cream, film or suppository (capsule) form — that reduces the infectivity of microbes, viruses or bacteria. It is applied topically to the vagina or rectum before sexual intercourse.

A microbicide has the capacity to kill, neutralise or block HIV and STI infection.

9.3 How Do Microbicides Work?

Microbicides can prevent HIV infection in any one of the following ways:

9.4 Benefits for People Already HIV-Infected

Microbicides will help to reduce the risk of re-infection for HIV-positive people and protect HIV-negative partners from HIV-infection. They will also help reduce the transmission of other sexually transmitted infections. Microbicides are able to allow for conception while protecting both parties from STIs.

It is important to note that microbicides are aimed to be used alongside condoms and should not replace condoms completely.

9.5 Research and Clinical Trials

Microbicides are not available to the public yet, but are projected to be released into the health sector in South Africa by 2007. To date, almost all research has been done by non-profit organisations, universities and small biotech firms.

Research has produced almost 60 products, which are poised for further testing.

Phase 3 trials are conducted by comparing two groups — those who receive the microbicide trial plus a standard prevention package and those who receive the prevention package plus a placebo gel. The placebo gel looks identical to the drug being studied, but doesn't contain the active ingredient.

All participants receive intensive condom counselling, free high-quality condoms and regular treatments for STDs. It normally takes about ten years for a product to develop into a fully tested product.

The three products which are among the closest to public release are:

Carraguard (PC-515)

Carraguard is a clear gel derived from seaweed, and it works by blocking the attachment of pathogens to target cells. It is effective against HIV, HSV-2, and gonorrhoea in vitro. It is currently undergoing phase 3 trials in South Africa and Botswana. Enrolment began in March 2004 in Pretoria, Cape Town and Durban.

Carraguard does not require refrigeration and can still retain effectiveness following lengthy storage. It does not have contraceptive properties .

PRO-2000/5

This is a naphthalene sulfonate polymer, and blocks attachment of pathogens to target cells. It is active against HIV-1 in vitro (in an artificial environment, e.g. test tube) and against HIV-1 and HSV-2 in vivo (in the body).

PRO-2000/5 does, however, have contraceptive properties, when tested in animals. It works by preventing any virus from entering the uterus. It has also shown effectiveness against multiple STD organisms.

It is still in Phase 2/2b trials. Enrolment began in February 2005. Three thousand participants enrolled in Durban and Hlabisa, South Africa; Lilongwe and Blantyre, Malawi; Moshi, Tanzania; Philedelphia,USA; Lusaka, Zambia; Harare and Chitungwiza, Zimbabwe.

Buffer Gel (Carbomer 974P)

This is an aqueous gel, which employs an agent which is widely used in pharmaceuticals and which helps maintain the vagina's natural acidity in the presence of sperm. Buffer gel is used in the manufacture of lipsticks, hand lotion and vaginal lubricants. This compound inhibits HIV, genital herpes, chlamydia, HVP and gonorrhoea.

Enrolment trials began in February 2005 with 3000 participants from South Africa, Malawi, Tanzania, Philadelphia, Zambia and Zimbabwe.

9.6 Distribution

Ideally, microbicides should be available at the same places condoms are commonly found:

•  government health and family planning clinics
•  pharmacies
•  community-based distributors and through village health workers
•  local shops, beauty parlours, taxi stands, markets and convenience stores
•  youth organisations, women's groups and through sex workers

A number of characteristics have to be considered such as bio-stability, shelf life, and storage requirements.

Health-care clinics, pharmacies and various health programs will be routes for distributing both prescription and over-the counter (OTC) products. In this way, education, counselling and support for potential users can be provided.

Several studies have shown that women and men would like to obtain microbicides through the formal health system.

9.7 Microbicide Reliability and Acceptability

For a microbicide to be acceptable, it has to fill the following criteria:

•  be safe,
•  be available over the counter
•  be affordable
•  be odourless
•  be easy to apply
•  not interfere with sexual pleasure
•  allow for application several times during intercourse

The first generation of microbicides to reach the market are expected to be 50-60% effective in preventing HIV infection, with the protection rate going up to 80-90% by the third generation as products are improved.

If microbicides are to have any impact at all on the HIV/AIDS epidemic, they have to be accessible to girls and women who are at the highest risk of contracting HIV. There has been concern, however, that in certain circumstances such as "dry sex", and where cleaning and drying agents are used, microbicides may not be as acceptable.

Even with these concerns, microbicide use and acceptability has varied. Evidence collected from countries such as Belgium, Brazil, Thailand, South Africa, Uganda, UK, US and Zimbabwe suggest the following:

Before microbicides are actually introduced, a framework will have to be developed for their introduction, promotion and delivery. The sooner this occurs, the better prepared policy makers will be for reaching decisions about the adoption of microbicides.

9.8 The South African Context

In South Africa, a research study conducted by International Family Health, found:

10. Key References

General

Condoms

HIV/AIDS Education

Mother-to-Child Transmission

Post Exposure Prophylaxis

Blood Screening

Prevention and Treatment of Sexually Transmitted Infections