South African Studies on HIV in Adolescents Project
The HIV epidemic in sub-Saharan Africa is being driven largely by new infections in adolescents, particularly young women. As a result, there is concern that any effective prophylactic vaccine licensed in adults would at the same time need to be licensed in adolescents and preadolescents. This would require testing of this product in this age group.
While it is recognized that vaccine development is a biomedical concern, efficient implementation will require understanding of the broader issues relating to participation. In order to generate and develop this understanding, the Desmond Tutu HIV Centre (DTHC) has initiated a project and received funding for this from the European and Developing Countries Clinical Trials Partnership (EDCTP). This project has the broad aim of identifying clinical, community, ethical, legal and socio-behavioural obstacles to the conduct of adolescent HIV vaccine trials and prevention interventions in South Africa and to address these obstacles through:
- the development of culturally-appropriate tools
- site capacity building
- development of adolescent-friendly services
- initiation of a strong and sustainable consortium of investigators.
The project includes two studies to be implemented nationally across seven sites. These sites are located in Cape Town, Soweto, Durban, Pretoria, Klerksdorp, Umtata and Mpumalanga.
Study 1
The first of these studies will use the licensed HPV vaccine, an alternative STI vaccine, as a proxy for an HIV vaccine and thereby identify potential challenges to the inclusion of adolescents in HIV prevention trials. The study will allow for site capacity building in terms of recruiting and retaining an HIV-negative high-risk adolescent cohort, and assessing the acceptability of an STI vaccine to adolescents and their parents or guardians.
Correlates of vaccine uptake, refusal, retention and attrition will be determined. In addition, the study will document the incidence of HIV, other sexually transmitted infections (STI's) and pregnancies and circumcisions in this age group. Different methods of assessing understanding in adolescents will be tested, to ensure that informed consent is being achieved. Experiences of privacy and confidentiality issues for adolescents in such research will be explored. The impact of receiving the vaccine on sexual risk behaviour over time will be monitored. Finally, psycho-social correlates of sexual risk and protective behaviour will be examined.
The study is designed as a longitudinal cohort study with a self-selected intervention and control group. Adolescents and parents will be recruited through community outreach and invited to attend a Vaccine Discussion Group (VDG) to learn more about the HPV vaccine. Parental/ legal guardian consent and adolescent assent will be obtained prior to screening. After screening to ensure volunteers meet inclusion criteria, 1400 participants will be enrolled across seven sites. At this point, they will decide whether or not they want to receive the HPV vaccine. Those who do will receive three doses, at 0, 2 and 6 months. All participants will undergo HIV and pregnancy testing, receive risk reduction counseling and complete questionnaires at 0, 2, 6 and 9 months. Recruitment and retention will be monitored and data as described above will be collected throughout the course of the study.
Study 2
The second study aims to explore community (parents, stakeholders and adolescents) attitudes towards adolescent participation in HIV vaccine trials and parental willingness to consent to adolescent participation, including attitudes toward age of consent and adolescent privacy. Requirements for an adolescent-friendly sexual health service will also be explored with participants, including attitudes towards circumcision, VCT and risk reduction counseling. In addition this study will facilitate the development of partnerships with key community members and representatives for key organizations and agencies important in reaching at risk youth as well as representative youth and their parents.
This study is designed as a cross-sectional qualitative study. Potential stakeholders in the community will be identified by performing an audit leading to the generation of a list of community stakeholders and relevant representative organizations. This list will include local CBOs, NGO's, youth organizations and women's organizations. Representatives from these groups will be contacted and invited to take part in focus groups. Adolescents and parents will be recruited through community outreach. Each focus group will consist of no more than eight participants and will be facilitated by an interviewer with appropriate skills, experience and training. These discussions could take between 1 to 2 hours and will be audio-recorded with the consent of the group to aid with accurate records as well as to maximize the interviewer's role as facilitator.
In addition to the research being conducted, community engagement and service development are also part of the project which has the ultimate aim of capacity building. Adolescent Community Advisory Boards (CABs), who will form a link and liase between researchers and adolescents in the community, will be established at each site. The Desmond Tutu site in Cape Town already has an established adolescent CAB called the Future Fighters, as does the Soweto site, and these CABs will guide the formation of CABs at the other sites. Communication and collaboration across CABs nationally is also planned. Adolescent-friendly sexual health services will also be developed at each of their sites, with the aim of creating a comfortable and confidential environment for adolescents to seek information, advice and treatment on sexual matters, where they will be respected and not judged.
Thus far, the project has led to the development of the Consortium of Adolescent Trials in Southern Africa (CATSA). This consortium is made up of the investigators from the seven different sites involved in the SASHA project, as well as number of experts on adolescent issues.
CATSA aims to address the challenges of the adolescent HIV epidemic in Southern Africa through building a network of established clinic sites, and a strong consortium of skilled investigators committed to working with adolescents, to be fully involved in biomedical and psychosocial research projects focusing on prevention and treatment of sexually transmitted disease in adolescents in Southern Africa, and committed to the highest ethical and legal standards. This consortium, which includes sites that can host future research projects will enable the continuation of much needed adolescent research beyond the SASHA project.
By the end of this project all seven sites will be prepared for the conduct of adolescent HIV vaccine trials. The sites will be equipped to provide adolescent-friendly health care services and will be prepared for adolescent recruitment and retention. We will have HIV, STI and pregnancy rates for adolescents at each of the site communities. We will have an understanding of adolescent, parent and community attitudes, motivations and concerns. Each site community will be represented by an adolescent CAB. Finally, we will have established a sustainable consortium of skilled investigators committed to conduct adolescent HIV vaccine trials.
* The project name was created by the CAB at Ndlela and means ‘we burn / it burns' in Zulu, reflecting the fact that HIV prevention in adolescents is a burning issue needing urgent attention in South Africa
