Cultural Barriers Keeping Kenyan And Ugandan Women Out of Aids Vaccine Trials

Reprinted from The East African (Nairobi) August 4, 2003

The participation by women in HIV/Aids vaccine trials in Kenya andUganda has been hampered by cultural inhibitions, scientists in thetrials said last week.

Trials of a vaccine that promises to provide a solution to theHIV/Aids scourge are currently under way in Kenya and Uganda, but theparticipation of women has been low.

The scientists said that this low participation by women, who aremore vulnerable to infection than men, could hinder comprehensiveconclusions on the efficacy of the vaccine.

Uganda has so far seen a 70 per cent enrolment for the trials, ofwhich only 10 per cent are women. The country needs at least 50 womenvolunteers. The first woman volunteer was enrolled in February, whilethe fourth woman enrolled in mid July.

Since the enrolment started in Kenya two months ago, 32 volunteershave been enrolled, eight of them are women. The Kenya site is inpartnership with the UK site and together they need 112 volunteers.

Medical officers say that for comprehensive conclusions to thevaccine trials in both sexes, a substantial number of women have toparticipate.

"The ideal number of females in the vaccine trials would be a thirdof the overall total," a senior trials physician, Dr Fred Nakwagala,said. "We make conclusions according to the data obtained, and inthis case, the evidence would be obtained only from men. It will meana delay for the females, who are more prone to the disease."

In African culture, a woman has little say about sexual matters in afamily. The fact that participation in this trial revolves around thesexual life of a couple makes it difficult for women to becomeinvolved in it, said a member of the Community Advisory Board (CAB)in Uganda.

CAB comprises opinion leaders in Kampala and Entebbe where the HIVvaccine trial is taking place. They provide advice on matters relatedto vaccine recruitment and enrolment at the clinical trial.

"We think that their husbands have not allowed them to come backbecause during the sensitisation seminars the turn-out was 50/50 formen and women," said Dr Fred Nakwagala.

Dr Nakwagala added that all four women enrolled for the Ugandavaccine trials were single mothers, who would have more freedom inmaking their own decisions than married women who usually need theconsent of their husbands.

Moreover, women also had the burden of looking after the home and somight not have enough time to report to the vaccine sites.

Volunteers are supposed to report to the vaccine site at least 18times. Other requirements are that the women not become pregnant, orbe breast-feeding during the seven months of the trials.

"Most of the women volunteers are in the reproductive age group andare sexually active," said Dr Walter Jaoko, the clinical manager atthe Kenya Aids Vaccine Initiative. "Most find it hard to tell theirhusbands about volunteering; and the issue of discretion is left tothe volunteer." Medical Officers sign confidentiality agreements withvolunteers about identity secrecy.

He said that about 60 per cent of the volunteers enrolled at theNairobi site were single, while 40 per cent were married.

A CAB member, Rose Tumusiime, said women in a polygamous marriagebelieved that if they were of child-bearing age and usedcontraceptives, it gave their husbands an excuse to look for anotherwoman to bear children with.

On the hand, said Mrs Tumusiime, men believed that child-bearing wasa way of keeping women from infidelity.

Condoms, which are recommended for use during the trial, are alsofrowned upon, as they were perceived as instruments to promoteunfaithfulness and extra-marital relationships.

Moreover, many women of childbearing age had no control overdecisions on when to have sex and when to bear children, said anotherCAB member.

However, the doctors in the trail ruled out fears that because of thelow participation of women in the trials it would then be a "maleonly" vaccine, saying that the immune systems of men and women werethe same.

"Given the state of the global emergency, we do not know what isrequired for protection and it is only through testing vaccines thatwe can find out," said the president of the International AidsVaccine Initiative (IAVI), Dr Seth Berkley.

Scientists said that in regard to the immune response, there was nobasis for assuming that the vaccine would not work on women.

They said that the immune system of a woman was no different fromthat of a man. "But it is our desire that we get a sizeable number ofwomen for the vaccine trials because of special characteristics suchas pregnancy," said Dr Jaoko.

Dr Berkley said at the launch of the UVRI/IAVI vaccine trials inEntebbe last week, "We must be prepared for disappointing results,but we must remember that even negative results are important as theygive us critical clues as to how to move forward,"The Uganda Virus Research Institute (UVRI) and the non-profit International Aids Vaccine Initiative (IAVI) jointly run the Entebbe facility conducting research into a preventive Aids vaccine.

Dr Berkley said the quality of work in the laboratories was as good as that in any of IAVI's other sites. "Good clinical practices are followed and African scientists are taking their rightful place beside scientists in other parts of the world in attempting to solve this horrendous problem in the shortest time frame," he said.

Uganda and Kenya are both carrying out trials for the DNA/M- VA vaccine. Uganda, under Phase One Clinical Trials, is testing for the best dose and interval between DNA and MVA.

That is the dosage of the vaccine that would give the best response and what is the most efficacious interval doses between doses.

Kenya is testing for the best dose and the best route through which to deliver it in the body. Alternative routes include under the skin (subcutanously), in the muscle (intra-muscular) or applied on the skin.

"Doing so many parallel sites is more complicated and expensive than if we did them in a series," said Dr Berkley. "However, it shortens the time for completion of testing the vaccine."