SOUTH AFRICA: Microbicide trials - what's in it for participants?

Why would a woman volunteer to use a product that may or may not protect her from HIV infection, undergo a lengthy screening process and then commit to regular clinic visits for up to two years?

South African women make up a significant number of the thousands in the African continent who have volunteered to participate in clinical trials for microbicides - a range of female-controlled products in the form of gels, creams, sponges and vaginal rings, which scientists are hopeful will prove effective at protecting women from HIV and other sexually transmitted infections (STIs).

A number of microbicide products have proven safe and effective in laboratory tests, but before being approved for use by the general public they must be tested on women in areas of the world where HIV prevalence is high enough to yield incontrovertible results.

The challenge for scientists is to design trials that have sufficiently attractive benefits to recruit and retain participants, without offering what ethics committees would deem incentives or inducements.

Benefits

South Africa's Medicines Control Council mandates that trial participants receive a R150 (US$21) "reimbursement" to cover transport costs each time they visit a trial site. The money is usually more than enough, and undoubtedly provides at least some motivation for unemployed women surviving on small incomes.

"I heard from a friend about the free check-ups and the money," admitted Bathabile*, 34, from Soshanguve, a township north of Pretoria. She had hoped to participate in a trial of a microbicide gel, Carraguard, run by the Population Council, an international nonprofit organisation, but was excluded when she tested HIV positive.

Zanele, 27, also from Soshanguve, qualified to participate in the Carraguard trial and stayed with it for two years until it ended in March 2007. She spent her leftover reimbursement money on clothing, but said it was not her main reason for taking part.

"I wanted to know my [HIV] status and get STI treatment and pap smears," she told IRIN/PlusNews. "And I wanted to help other women, because I know women who've been affected by HIV."

According to Dr Claire Von Mollendorf, of the Reproductive Health and HIV Research Unit (RHRU) at the University of Witwatersrand, in Johannesburg, who has been involved in several microbicide trials, many women volunteered for altruistic reasons: "They want to help because they've all had family members that have died from HIV."
By, IRIN PlusNews, October 29, 2007

Most of the participants IRIN/PlusNews interviewed at Setshaba Research Centre in Soshanguve, one of three sites in South Africa where the Carraguard trial was conducted, cited the health benefits as their main reason for taking part: regular HIV tests, treatment for STIs, annual Pap smears, free condoms, and counselling on how to reduce their HIV risk.

"I miss the health services we got here," said Zanele. "Last week I went for an HIV test at the [public] clinic, and the nurses were rude and the queue was long, unlike here, where I would just come in and be attended to just like that."

Rivonia, 22, qualified for the trial and used the gel for three months before testing positive and having to drop out of the trial. Despite the initial shock of discovering her status, she had no regrets about her involvement. "I wouldn't have tested if it hadn't been for the trial," she told IRIN/PlusNews. "Even now, I wouldn't have known that I'm HIV positive."

Rivonia and Bathabile were among about 30 women - all of whom tested positive during the initial screening or became positive over the course of the three-year trial - who then joined a support group started by the trial staff. The group met weekly and attended cookery classes by a nutritionist, received health advice and referrals from a doctor, and support from each other.

Staying the course

Scientists need at least 80 percent of microbicide trial participants to use the product for periods of up to two years to obtain reliable results. In the case of Carraguard, which comes in the form of a gel, many women said they enjoyed using it because the gel acted as a lubricant, increasing sexual pleasure for themselves and their partners. Similarly positive feedback has come from other microbicide trials.

Jonathan Stadler, a social scientist with the RHRU who has interviewed women about their experiences during microbicide trials, said many reported liking the fact they could be using a product that might protect them against HIV and STIs.

"In a world of HIV and AIDS, where all we've managed to give people so far is the condom, and suddenly you get something which is so much nicer to use, the fact that this might actually be effective is a very attractive idea for most people," he said.

There is evidence that women who do not tell their male partners about their trial participation are more likely to drop out. Dr Khatija Ahmed of the University of Limpopo, principal investigator of the trial, said only about half the 2,400 women in the Carraguard trial in Soshanguve told their partners, and a small percentage of those dropped out when the partners discovered they were using the gel.

"It helps if the partner is involved, especially in terms of adherence, and also for the treatment of STIs, because we did offer treatment to partners as well," said Ahmed. "But this is a woman-based clinical trial. We advise participants to tell their partners, but it's really their choice, because different people have different relationships."

Zanele was six months into the trial before she told her boyfriend. "I was nervous because he takes long to understand these issues," she said. "Finally, he heard from other people that there's this gel and women are getting paid to use it, and then I told him. In the beginning, he didn't want to use it but after he heard what its purpose was, he said, 'let's use it'."

Some of the women in the Carraguard trial also attracted unflattering neighbourhood gossip, much of it related to their reimbursements. "People would say, 'Why should we get paid? It means the gel will infect us'," said Rivonia.

Von Mollendorf commented that "study fatigue" tended to set in after the first few months of a microbicide trial. "It becomes tedious for the women, and that's why, in the middle of your study, you try to have retention parties or events to encourage them to stay in the trial. You give them more information and updates from other microbicide trials."

Outcomes

The Carraguard trial, the results of which are expected by the end of the year, is the first microbicide trial to complete the final human effectiveness phase of testing. "The entire microbicide world and all the communities where the research was conducted are waiting for those results," said Ahmed.

Participants and the wider community will be informed about the results of the trial, and Ahmed is hopeful that if the product proves effective they wwill also be given priority in having access to it.

"The Population Council is already negotiating with various pharmaceutical companies with regard to manufacturing the product at a cost that is affordable to the people who need it," she said.

For her part, Zanele is looking forward to other studies coming to Soshanguve. "I would like to be in another trial," she said.

Source: http://www.plusnews.org/InDepthMain.aspx?InDepthId=64&ReportId=74136

Catholic Church's Opposition to Condom Use Contributes to Spread of HIV in Latin America, UNAIDS Official Says

By, Kaisernetwork, October 24, 2007

The Roman Catholic Church's opposition to condom use is contributing to the spread of HIV in Latin America, Alberto Stella -- UNAIDS coordinator for Honduras, Nicaragua and Costa Rica -- said on Monday, Reuters reports.

"In Latin America, the use of condoms has been demonized, but if they were used in every relation, I guarantee the epidemic would be resolved in the region," Stella said. He added that youth "start to be sexually active between 15 and 19 without sex education" -- a factor that contributes to the spread of HIV. In addition, evidence indicates that promoting abstinence is "not working," according to Stella.

About half of the 1.1 billion Catholics worldwide live in Latin America, and the Roman Catholic Church "holds sway" in the region, Reuters reports. About 1.7 million people in Latin America are living with HIV/AIDS. The number of new HIV cases in the region increased to 410,000 in 2006 from 320,000 in 2004, according to UNAIDS (Reuters, 10/23).

Israeli Doctors Providing Male Circumcision in Swaziland in Effort To Prevent Spread of HIV

By, Kaisernetwork, October 22, 2007

Teams of Israeli surgeons have begun providing male circumcision in Swaziland in an effort to prevent the spread of HIV, the Washington Post reports. Health officials in Swaziland, which has fewer than 100 doctors and the world's highest HIV prevalence, say that over the next five years, they hope to offer the procedure to 200,000 sexually active men at a rate of roughly 200 daily -- 20 times faster than the current pace. According to the Post, six Israeli doctors are scheduled to work for two weeks in Swaziland this year under a program organized by the Jerusalem AIDS Project and underwritten by the U.S.-based Jewish organization Hadassah and other donors.

The Israeli doctors primarily are expected to train Swazi doctors on how to perform circumcision among adult men. However, many Swazi doctors already know how to perform the surgery. According to some Swazi doctors, what they primarily need from the Israeli doctors are "extra hands to help get enough done to impact the epidemic," the Post reports. The demand for circumcision -- especially surgeries that are no cost or subsidized -- appears to "far outstrip supply in Swaziland," according to the Post. The health system "routinely runs low" on basic medical supplies -- such as sutures, gloves, dressings and surgical tools -- the Post reports. In addition, there is a "major constraint" on surgeons and doctors, Dudu Simelane -- executive director of the Family Life Association of Swaziland, a nongovernmental group hosting the Israeli doctors -- said.

Some Swazi surgeons have shown that they can each perform 10 circumcision procedures -- which take about 25 minutes -- daily during the country's occasional series of "Circumcision Saturday" events, the Post reports. According to medical experts, it would take four doctors at each of five separate facilities to perform 1,000 circumcisions weekly if Swazi doctors can maintain that speed every weekday (Timberg, Washington Post, 10/21).

In South Africa, AIDS takes toll on older women

By, Khadijah Rentas, Columbia Missourian, October 21, 2007

The image of rural older women surrounded by young orphans has become a symbol of the effects of HIV/AIDS on sub-Saharan Africa. With more and more working-age people dying of the disease, poverty can strike households quickly and without mercy.

Charities, international organizations and governments have united to combat HIV/AIDS in Africa, pouring millions of dollars into education, prevention and treatment efforts. This year, the South African government appropriated more than $539 million to improve health care facilities.

The effects of the disease are devastating, especially to South African women, who are infected at a much higher rate than South African men, according to statistics compiled by the United Nations. AIDS-related deaths in 20- to 39-year-old women tripled between 1997 and 2004, and 1.2 million South African children have been orphaned by the disease.

As a result, in a country where one in four is unemployed and half the population lives in poverty, many rural households are being held together by older women who rely on government pensions to feed, clothe and shelter large extended families. Designed to provide financial support for one person, the pensions are often the only source of income for rural families spanning several generations — children, grandchildren and even great-grandchildren, according to research conducted in Agincourt, South Africa, by an MU professor and colleagues from the University of Colorado and the University of Witwatersrand in Johannesburg.

Enid Schatz, director of social science research at MU’s School of Health Professions, and her fellow researchers set out to determine whether an older woman who had had an AIDS death in her household suffered greater economic stress than those who did not. The results, published in August, showed that the burden of caring for adult children and grandchildren in rural South Africa is falling on many older women, not just those whose families have experienced a death from AIDS.

“We expected to find very different situations, but we found more commonality,” Schatz said. “You don’t have to have an AIDS death in your household to be affected.”

In addition to daily living expenses, older South African women often must help other families with funeral expenses or help take in children whose parents have died. In many cases, the older women must also support unemployed adult children.

Schatz interviewed 60 older women between the ages of 60 and 75 years old in 60 households. Of those, 38 women received a government pension, which at the time was equal to about $100 a month. Out of 30 older women, 28 received pensions and only a third lived in a household where an adult had died in the last two years from AIDS-related causes. Most of the women were caring for children who had lost a parent to AIDS or who had a single parent who had migrated to another part of the country to find work and had to leave children behind.

“There’s been a long history in southern Africa of fostering children,” Schatz said. “But I think the magnitude of it and the burden of it is increased because the parents aren’t coming home.”

South Africa offers grant money for social programs aimed at children, but Schatz and her colleagues found that women had trouble accessing the funds because they lacked knowledge about the programs or did not have the necessary documents for eligibility, such as birth certificates.

Although the government aid helped, the research found that it was not enough to support an extended family. The study reported that most of the women said their pensions ran out before the next check arrived, sometimes as much as two weeks before.

“I think AIDS is to some degree another crisis,” Schatz said. “And there are other crises, like, ‘How am I going to pay school fees for children who are left behind?’ ”

The United States Agency for International Development, a government-sponsored relief program, allocated $252 million in aid for South Africa. That aid, which has increased more than $100 million since 2006, funds programs that focus on economic growth, peace, security and the HIV/AIDS pandemic. President Bush’s Emergency Plan for AIDS Relief allocated more than $363 million in 2007 to the prevention, care and treatment of HIV/AIDS, an increase of about $168 million since 2006.

According to the PEPFAR Web site, only 20 percent of the money has been allocated for prevention, one-third of which is for abstinence-only education, eclipsing spending on condom distribution and on education aimed at reducing the chance of mother-to-child transmission of the virus.

Although she has not compiled research on policy, Schatz said aid money typically does not trickle down to the people she works with. Older women interviewed by the researchers said the best thing the South African government could do to ease their burden would be to increase their monthly pensions. Since the research’s publication in August, the pension has been increased by $25 a month.

According to the Global HIV Prevention Working Group, which is supported by the Kaiser Family and the Bill and Melinda Gates foundations, new HIV infections in sub-Saharan Africa will increase by 36 million by 2015.

Yusuf Kalyango, a native of Uganda who teaches international reporting at MU, said poverty, coupled with a lack of education, has fostered the spread of the disease, making it more difficult to control in the future. As Schatz’s research suggests, the burden will fall heavily on South Africa’s older women.

“Illiteracy, poverty and general ignorance will contribute to the spread of HIV,” Kalyango said. “Two things have to happen simultaneously, and that is economic empowerment and education. If citizens are not educated, they cannot be empowered.”

Source: http://www.columbiamissourian.com/stories/2007/10/21/south-africa-aids-takes-toll-older-women/

HIV/AIDS Prevention Among MSM in China Remains a Challenge, Health Official Says

By, Kaisernetwork, October 19, 2007

Preventing the spread of HIV among men who have sex with men remains a challenge for the Chinese government, Wang Yu, chief of the Chinese Center for Disease Control and Prevention, said on Wednesday, China Daily reports. The United Nations and the Asian Development Bank in a recent report said the number of HIV cases in China is rising faster than the average number in most Asia-Pacific countries despite efforts by the government.

According to Wang, more than half of the new HIV cases reported in the country this year as of June were among MSM and commercial sex workers. He did not disclose how many cases had been reported so far this year but said that there are 60,000 to 70,000 new cases reported annually in the country.

MSM are "one of the high-risk groups vulnerable" to HIV transmission and account for nearly 25% of new cases, Wang said, adding that China's "prevention efforts among them have done nearly nothing to stem the rate" of transmission. He said it is difficult to reach MSM because of stigma. According to Wang, preventing the spread of HIV among MSM is crucial because it is "very common for them to spread [HIV] to their families." Wang said that health officials still are working on a package of measures aimed at MSM. He added that officials are training volunteers and "sending them out to spread" awareness in the MSM community (Fu, China Daily, 10/18).

Vietnam Should Improve Efficiency of HIV/AIDS Control Programs To Reduce Impact, Spread of the Disease, Deputy PM Says

By, Kaisernetwork, October 15, 2007

Vietnam needs to improve the efficiency of its HIV/AIDS control programs to reduce the impact and spread of the disease in the country, Deputy Prime Minister Truong Vinh Trong said on Friday at the end of a two-day conference on HIV/AIDS prevention in Hanoi, Vietnam, the Vietnam News Brief Service reports. "Localities nationwide have made efforts in implementing HIV/AIDS prevention activities; however, the efficiency is not high," Trong said, adding that 18 of the country's 60 cities and provinces have faced challenges in implementation.

According to Trong, Vietnam's relevant ministries and agencies should promote increased cooperation with international organizations and implement interventions to reduce the spread of the disease from high-risk groups to the general population. Trong asked the relevant ministries to issue practical plans and measures to help accomplish the national strategy on HIV/AIDS prevention, which aims to keep Vietnam's HIV/AIDS prevalence at less than 0.3%. As of Aug. 30, the country recorded 128,367 people living with HIV, 25,119 of whom had developed AIDS. The country also recorded 14,042 AIDS-related deaths, the Vietnam News Brief Service reports. It is estimated that Vietnam will have about 351,000 people living with HIV, including 157,000 people living with AIDS, by 2010 (Vietnam News Brief Service, 10/12).

In related news, Vietnam recently announced it plans to invest 1,352 billion Vietnamese dong, or about $84.5 million, in HIV/AIDS prevention activities between 2007 and 2010, Xinhua/People's Daily reports. Most of the funds will be used to prevent new HIV cases among high-risk groups and the general population. Some of the funds also will be used to intensify training for health professionals, Xinhua/People's Daily reports (Xinhua/People's Daily, 10/12).

New HIV Cases Among Married Couples in Thailand Increasing, Survey Says

By, Kaisernetwork, October 15, 2007

The percentage of new HIV cases recorded among married couples in Thailand has increased from 38.7% of new diagnoses in 2005 to 40% of new diagnoses in 2006, according to a recent survey by Thailand's Department of Disease Control, Thailand's Nation reports.

According to the survey, between 44% and 52% of married couples in the country engage in unprotected sex. The survey also found that 22% of new HIV diagnoses were among men who have sex with men. In addition, 11% of men who are newly diagnosed contracted the virus from commercial sex workers, and 10% contracted the virus from their partners, the survey found.

Thawat Suntrajarn, chief of DDC, said the agency has a plan in place to prevent the spread of the virus, particularly among married couples. The DDC and Ministry of Public Health plan to provide 20 million condoms in hospitals to couples living with HIV/AIDS to combat the spread of the virus. In addition, the health ministry will provide HIV-positive people with 10 condoms monthly and antiretroviral drugs at no cost. DDC also will provide 10 condoms monthly to HIV-positive people who do not show symptoms and will encourage their partners to receive HIV tests.

South Africa: When microbicide trials go wrong - Part 2

By, IRIN PlusNews, October 12, 2007

It's an overcast Thursday morning in the port city of Durban, on South Africa's east coast, and some of the former participants in a microbicide trial, discontinued earlier this year, have gathered at the now deserted research site behind a busy downtown taxi rank, to be interviewed by IRIN/PlusNews.

The trials of a microbicide candidate containing cellulose sulphate were stopped after preliminary results showed it could increase the risk of HIV infection.

CONRAD, a reproductive health research organisation, was carrying out the trials in Benin (West Africa), India, South Africa and Uganda, and is conducting more tests to find an adequate scientific explanation for the higher number of seroconversions (HIV infection) in the cellulose sulphate arm of the study.

In South Africa, public outrage over the results was heightened by sensational media coverage depicting the participants in microbicide trials as 'human guinea pigs', and alleging that the women were encouraged to visit bars and other similar places of entertainment, and to engage in unprotected sex.

Street smart, articulate and well informed about their rights, the six participants PlusNews spoke to are no 'guinea pigs'; they all emphasise the benefits of the gel, and how they were not "forced" to join the study. But they're also not really clear about why the trial was stopped, and all they want to know is, "When will the gel become available again?"

At the time the trial ended, Nokuthula Lefora, 37, was one month away from completing her 12 months of using the gel and really enjoyed using it, as it enhanced her sex life. "When you use it, you become aroused and moist and you feel good." Participants on the trial were required to insert the gel in the vagina an hour before sex, using an applicator, and to use it with a condom.

The married mother of four first heard the rumours in her informal settlement that a group of women were claiming to have been infected after using the potential prophylaxis. She subsequently received a telephone call from researchers at the Medical Research Council, alerting her to the premature end of the trial and telling her to stop using the gel and return it to the research site.

Then the news broke in the media. "When I heard about this on TV and radio, about women who were told to go to shebeens and have sex with a lot of men, I was confused; I thought, 'They can't be talking about my trial, because it didn't sound like the one I was on.'"

A presentation in July by the local researchers on why the microbicide trial had been discontinued doesn't seem to have convinced Lefora though, as she maintained that the women who seroconverted were "troublemakers" who became HIV-positive because they did not use the gel properly. She has recently been for an HIV test and is negative, and told IRIN/PlusNews that she would use the gel again - despite the fact that "it didn't pass".

What happened to the women?

When Nomusa (last name withheld) heard that the trial had been stopped, her initial reactions were fear and panic. Now, almost a year later, HIV negative Nomusa misses the regular health screening she received at the research centre, as well as the friends she made. The last time she had a PAP smear test was in 2006 during the trial, and she doubts she'll be able to have the test at her local clinic.

"Forget about the R150 they used to give us; it helped so many people to be on this thing. We got tested, and I know some of the women I came with found out they were HIV here. They are now getting help ... before we came here, some people didn't even know that condoms expire," she commented.

At the offices of the Medical Research Council's (MRC) HIV Prevention Unit, which is responsible for several microbicide trials being carried out in South Africa, Dr Roshini Govinden, the principal investigator of the Durban cellulose sulphate trial, told IRIN/PlusNews that the participants were "disappointed" when the trial was halted.

"We started calling them immediately, and told them to stop using the gel and come to the clinic to bring [it] back ... and we even offered to send someone to pick it up," she said. "A lot of them did come back and we got all the product back ... except for one woman who was a little bit annoyed and accused us of trying to give her HIV. She never came back."

The partner of one participant burnt her gel supplies, while the male partners of women in other microbicide trials run by the MRC raised concerns that using "gel" increased HIV risk, and did not want them to participate in the trials.

Former participant Nelisiwe (not her real name), who had recruited other women to enrol in the study, found out the trial had stopped via phone calls and text messages from women she had encouraged to join. "They were asking me, 'Have you heard about your gel? They say it has HIV'".

Nelisiwe and her 22-year-old daughter, who also participated in the trial, had already finished their 12-month trial period by this time, and both are still negative. The six women interviewed by PlusNews were all HIV negative, and those who had seroconverted during the trial have been reluctant to speak to the media.

The standard of care for women who become HIV positive during microbicide trials is a hotly debated issue: should researchers be obliged to offer the best possible care, the standard of care in the host country, or something between?

According to Govinden, all the women who seroconverted during the trial have been referred to healthcare facilities, and HIV-positive participants can access free CD4 count and viral load tests, as well as treatment for opportunistic infections, at a nearby HIV/AIDS clinic supported by the US President's Emergency Plan for AIDS Relief (PEPFAR). She said the women also received intense counselling.

Ntokozo Madlala, advocacy officer for the Gender AIDS Forum, told IRIN/PlusNews that access to care for women who had seroconverted during trials was still a patchy issue, as there was "no uniform standard of care" and some research organisations offered better HIV care services than others. "It depends on who is funding it and sponsoring the trials," she said.

The Global Campaign for Microbicides has called on all trial sponsors to set up mechanisms to ensure that participants have access to HIV care before trials begin. Care is usually arranged in partnership with local facilities, or the creation of a reserve fund to pay for treatment.

Many trials also try to facilitate access to care for women who test HIV positive at screening, by providing CD4 tests and other tests that can help them qualify for local treatment programmes.

Keeping the momentum going

That there will be more trial failures cannot be ruled out. But it doesn't help that the country's AIDS activists have been slow to become involved with microbicides, and there are no "strong and visible" advocates and watchdogs for the potential prevention tool.

Madlala admitted that many NGOs have been "too relaxed" about closely following the microbicide research process, choosing instead to pursue "sexier and more urgent" issues, like treatment.

"I don't think you can be an activist and shut out issues looking into prevention for women," she said. "It's a pity, because the research field is moving at a very fast pace. South Africa is becoming the place for microbicide trials, but we as advocates need to get our act together, because some of us still don't know what a microbicide is, or how clinical trials work."

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