EDCTP portfolio: Career Development Fellowships

Dr Yunia Mayanja aims to assess ways to involve at-risk adolescents (14-19 years old) in HIV prevention and prevention research.

Assessing how to enroll and retain adolescents at risk of HIV infection

Despite the fact that adolescents are involved in risky behaviours such as early sexual debut, multiple sexual relationships, alcohol and substance use, there are not many adolescent-friendly services, whether for research, prevention or treatment. However, there are substantial benefits to the involvement of adolescents in health research for both HIV-positive and HIV-negative adolescents and their peers.

The challenge is to devise ways to involve adolescents in research, prevention and treatment.

The challenge

Dr Mayanja and her team care conducting a feasibility cohort study to assess whether at-risk adolescents in the age 14-19 years can be enrolled from hotspots and followed up regularly in a research clinic.

A three-year cohort study is conducted which uses recruitment and retention strategies to enrol and follow up a closed cohort of 500 adolescents (20% male) aged 14-19, resident in Kampala and involved in sex work. At baseline data on social demographics, sexual behaviour and knowledge and uptake of HIV prevention methods contraceptive use, substance use, gender-based violence are collected. Qualitative data are collected on individual and contextual barriers to participation in HIV prevention research.

Secondly, participants will receive biological testing for hepatitis B, gonorrhoea and chlamydia at enrolment, HIV testing every 3 months and syphilis testing every 6 months.  HIV counselling and testing, risk reduction counselling for HIV, STIs, and substance abuse, contraception, STI screening are provided as well as treatment at baseline and periodic presumptive treatment at follow-up, with free condoms and health education every three months.

The primary objectives are to: assess the feasibility of recruiting at-risk adolescent volunteers into a research clinic; determine baseline HIV prevalence and estimate HIV incidence; and, estimate the annual retention rate. Secondary objectives are to: estimate the baseline prevalence of sexually transmitted infections; determine the acceptability of periodic presumptive treatment for sexually transmitted infections; determine reproductive health outcomes of volunteers; determine the prevalence of substance use and gender-based violence; and, explore facilitators and barriers to participation in HIV prevention research using qualitative methods.

The project

Dr Mayanja expects that the study will provide preliminary data on the burden of health problems of adolescents residing in hotspots and/or involved in sex work. It will also inform the improvement of recruitment and retention strategies for a larger study to deliver a combination of HIV prevention services (including an education intervention on biomedical HIV prevention) and assess the preparedness of volunteers for HIV prevention trials.

Impact


test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Despite the fact that adolescents are involved in risky behaviours such as early sexual debut, multiple sexual relationships, alcohol and substance use, there are not many adolescent-friendly services, whether for research, prevention or treatment. However, there are substantial benefits to the involvement of adolescents in health research for both HIV-positive and HIV-negative adolescents and their peers.

The challenge is to devise ways to involve adolescents in research, prevention and treatment.

Dr Mayanja and her team care conducting a feasibility cohort study to assess whether at-risk adolescents in the age 14-19 years can be enrolled from hotspots and followed up regularly in a research clinic.

A three-year cohort study is conducted which uses recruitment and retention strategies to enrol and follow up a closed cohort of 500 adolescents (20% male) aged 14-19, resident in Kampala and involved in sex work. At baseline data on social demographics, sexual behaviour and knowledge and uptake of HIV prevention methods contraceptive use, substance use, gender-based violence are collected. Qualitative data are collected on individual and contextual barriers to participation in HIV prevention research.

Secondly, participants will receive biological testing for hepatitis B, gonorrhoea and chlamydia at enrolment, HIV testing every 3 months and syphilis testing every 6 months.  HIV counselling and testing, risk reduction counselling for HIV, STIs, and substance abuse, contraception, STI screening are provided as well as treatment at baseline and periodic presumptive treatment at follow-up, with free condoms and health education every three months.

The primary objectives are to: assess the feasibility of recruiting at-risk adolescent volunteers into a research clinic; determine baseline HIV prevalence and estimate HIV incidence; and, estimate the annual retention rate. Secondary objectives are to: estimate the baseline prevalence of sexually transmitted infections; determine the acceptability of periodic presumptive treatment for sexually transmitted infections; determine reproductive health outcomes of volunteers; determine the prevalence of substance use and gender-based violence; and, explore facilitators and barriers to participation in HIV prevention research using qualitative methods.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

Dr Mayanja expects that the study will provide preliminary data on the burden of health problems of adolescents residing in hotspots and/or involved in sex work. It will also inform the improvement of recruitment and retention strategies for a larger study to deliver a combination of HIV prevention services (including an education intervention on biomedical HIV prevention) and assess the preparedness of volunteers for HIV prevention trials.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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