HIV-1-infectionPeers for PREPNCT05516602
Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda
A study testing Peer Support in people with HIV-1-infection, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
Trial summary
Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP. Main Study Aim: To evaluate a peer support intervention aimed at improving uptake of and adherence to oral pre-exposure prophylaxis (PrEP), and its effect on sexual behavioral and… Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Peer Support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteUganda
- Study dates
- 12 Jan 2023to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV negative (assessed through rapid blood test)
- Sexually active in the past 3 months
- 14-24 years
- Hepatitis B negative for those who initiate oral PrEP
- Willing to undergo study procedures
Who cannot join
- HIV infection
- Currently taking oral PrEP
- Known allergy to common medications, components of oral PrEP or contraceptives
- Pregnant
- An acute or chronic illness that may affect volunteer participation or achieving study objectives
- A condition or situation that in the opinion of the PI/designee would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP.
Main Study Aim:
Read more
To evaluate a peer support intervention aimed at improving uptake of and adherence to oral pre-exposure prophylaxis (PrEP), and its effect on sexual behavioral and reproductive health outcomes
Study Objectives:
- To evaluate the effect of a peer support intervention on uptake of and adherence to oral PrEP among 14-24-year-old AGYW at risk of HIV infection in Kampala, Uganda. ii. To evaluate the effect of the peer support intervention aimed at improving oral PrEP uptake and adherence, on sexual behavior and reproductive health outcomes among AGYW in Kampala, Uganda.
Design An individually randomized controlled trial with parallel group design and 1:1 randomization in the intervention and control arms.
Population: 14-24-year old AGYW at risk of HIV infection in Kampala.
Control arm: Standard health worker counselling during clinic visits.
Intervention arm: Standard health worker counselling during clinic visits + peer support groups over the weekend.
Read the detailed description
1 INTRODUCTION 1.1 Background Adolescent girls and young women (AGYW) aged 15-24 years in Sub-Saharan Africa (SSA) are at substantial risk for HIV infection and in 2020, AGYW accounted for 32% of new HIV infections in East and Southern Africa [1]. In the general population in Uganda, the HIV prevalence among AGYW is estimated at 1.8% among 15-19 year-olds and 5.1% among 20-24 year-olds [2]. The prevalence among AGYW living in fishing communities in Uganda, and young female sex workers (FSWs) is even higher estimated at 15.4% and 22.5% respectively [3, 4]. During recent years, biomedical interventions for HIV prevention have been developed and are currently at different stages of the pipeline with some already approved for use. For example, anti-retroviral (ARV) implants for pre-exposure prophylaxis (PrEP) to protect HIV negative girls from becoming HIV infected, have recently been assessed in pre-clinical studies [5, 6]. Other biomedical interventions for HIV prevention among vulnerable HIV negative sub-groups, including AGYW in SSA, have further been assessed in clinical trials for example: the Dapivirine vaginal ring (DVR) [7, 8], long acting injectable PrEP [9, 10], HIV vaccines [11] and oral PrEP [12, 13]. Oral PrEP is a single pill taken once daily during periods of risk to HIV infection, and is highly efficacious when adherence is good (>90%) [12]. Tenofovir is one of the most common HIV drugs and tenofovir-based oral PrEP is also one of the World Health Organization (WHO) approved biomedical HIV prevention interventions [14, 15]. In 2016, the Uganda government approved use of oral PrEP for HIV prevention among individuals at substantial risk of HIV infection [16], and increased access to targeted key populations including AGYW. The HIV prevention landscape is promising as other novel biomedical HIV prevention interventions are in various stages of development, including long acting injectable PrEP, anti-retroviral (ARV) implants and HIV vaccines. The Dapivirine vaginal ring is approved by WHO as an additional HIV prevention choice for women [17], has been approved for use in South Africa [18] and, has been added to the drug register of the National Drug Authority in Uganda [19]. Injectable cabotegravir may also be available soon having shown efficacy in the HIV Prevention Trials Network (HPTN084) study [10]. End-user preferences for HIV prevention products may predict method uptake [20] and there is a need to increase researchers' knowledge about current preferences for HIV prophylaxis among AGYW in SSA who continue to be at substantial risk of HIV.
1.2 Oral PrEP Uptake and Adherence among Adolescent Girls and Young Women Oral PrEP is still currently the only available biomedical HIV prevention method in most parts of SSA. PrEP implementation projects have been facilitated through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) funding. Despite the potential benefits in HIV prevention, uptake and adherence to oral PrEP remain low among AGYW in Uganda and other parts of SSA [21, 22]. A recent study among AGYW in Kampala, Uganda, with high reported prevalence of being engaged in sex for compensation, also found a low oral PrEP uptake (31%) in this population [23]. The study also found that the uptake was higher in respondents with more sexual partners and among those who showed higher preference for oral PrEP over other biomedical HIV prevention methods when asked at enrolment. Importantly, tests for Tenofovir levels in blood showed very low adherence. Conversely, the Prevention Options for Women Evaluation Research (POWER) project which also enrolled 16-25-year-old AGYW in Kenya and South Africa reported high PrEP uptake (90%) associated with higher risk behavior, intimate partner violence (IPV), depression and chlamydia/ gonorrhea diagnosis [24]. Despite high PrEP uptake, the POWER project reported early discontinuation of PrEP use due to side effects, challenges with accessing services and product characteristics such as need for daily dosing [24, 25]. Other studies have identified pill burden, side effects [21, 22], low risk perception [26, 27] and limited awareness of oral PrEP [28] as barriers to PrEP uptake among AGYW in SSA. Interviews with potential PrEP users in multiple settings in central Uganda also showed that stigma, transport costs to get PrEP refills, accessibility, busy schedules, and forgetfulness were barriers to PrEP uptake while closeness of PrEP providers to one's home was a facilitator [29]. Thus, there is a need for interventions that may promote PrEP use among AGYW populations in SSA who are at increased risk of HIV infection.
1.3 Rationale Peer-to-peer support is one of the strategies proposed for improving HIV prevention and promotion of safer sexual behaviors in the Uganda National HIV research agenda [30], but there is limited evidence of its effectiveness in PrEP programs. Studies show that young people easily take on behaviors when in groups than as individuals, easily adopt behaviors and norms of their peers [31, 32], and are more easily affected by peer influence compared to children and older adults [33]. Among young people living with HIV in Zimbabwe, peer-led psycho-social support services among HIV positive individuals led to a 13% decrease in detectable viremia at 6 months compared with counselling delivered by health care workers (HCWs) [34]. A recent study among refugee adolescents in Northern Uganda showed same day acceptance of contraception was 9% higher among those who received peer counselling compared to counselling provided by HCWs [35]. In addition, trained peers have led to improvements in the HIV care and treatment cascade and contraceptive use through peer counselling, peer support for example delivery of interventions, peer referral etc. [36, 37]. Previous evidence suggests that peer counselling and support interventions have improved HIV testing, utilization of health care services, anti-retroviral therapy (ART) initiation, adherence to treatment, adherence to HIV viral load testing at 6 months and HIV viral suppression among young people living with HIV in Zimbabwe [37, 38]. Peer support interventions may therefore also improve oral PrEP uptake and adherence, and also reduce sexual behavior risk among AGYW, but this has not been widely studied.
- STUDY AIMS AND RESEARCH QUESTIONS 2.1 The main aim of this project is to evaluate the effect of a peer support intervention on oral PrEP uptake and adherence, sexual behavioral and reproductive health outcomes of 14-24-year-old AGYW who are at high risk of HIV infection.
2.2 Research Questions i. What is the effect of a peer support intervention on uptake of and adherence to oral PrEP among AGYW aged 14-24 years at high risk of HIV infection in Uganda? ii. What are the effects of a peer support intervention for oral PrEP uptake and adherence on sexual behavior and reproductive health outcomes of AGYW aged 14-24 years at high risk of HIV infection in Uganda?
The investigators hypothesize that the peer support intervention will: (i) improve oral PrEP uptake and adherence among AGYW; (ii) reduce sexual behavioral risk, pregnancy and sexually transmitted infection (STI) rates
- Conditions
- HIV-1-infection
- Being tested
- Peer Support
- Keywords
- Adolescent Girls and Young Women, Oral PrEP, Peer Support, Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportOther
Peer-led support groups over the weekend will include the following activities:
- Peer leader counselling on oral PrEP and HIV risk reduction
- Peer leader discussion to dispel myths and misconceptions around oral PrEP
- Peer leader sharing of experiences of daily pill taking
- Participants sharing experiences of influencers and barriers to oral PrEP uptake and adherence followed by a discussion by group members.
- 1-2 role plays per support group session.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support | Experimental | Standard health worker counselling during clinic visits plus peer support over the weekends. Receives: Other: Peer Support |
| Standard | No intervention | Standard health worker counselling during clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of enrolled participants who take up oral PrEP after randomization to peer support or the standard
Number of participants who take up oral PrEP divided by the total number enrolled. PrEP uptake was measured as a participants accepting the offer of oral PrEP and picking their first month's supply from the clinic.
Measured: Measured from enrolment to the end of follow up at 12 months
The proportion of volunteers who take up oral PrEP and adhere to oral PrEP after randomization to peer support or the standard
Number of participants who adhere to oral PrEP divided by the total number taking oral PrEP. Adherence was measured using self reports, pill counts and rapid urine tenofovir kits
Measured: 3 monthly measurements from enrolment to the end of follow up at 12 months
Time in days to oral PrEP uptake from the date it is offered after randomization to peer support or the standard.
Number of days from the date a participant is offered oral PrEP to the date they pick the first month's supply from the clinic.
Measured: Measured from enrolment to the end of follow up at 12 months
Secondary outcomes (4)
Total number of sexual partners in the past 3 months in the peer support group compared to the standard
Proportion of participants having a specific risk score for total sexual partners in the past 3 months comparing the peer support group and the standard. Risk scores 1-4 assigned for number of sexual partners in the past 3 months as follows:
- 0= no sexual partners
- 1= 1 sexual partner
- 2= 2-4 sexual partners
- 3= 5-9 sexual partners
- 4= ≥10 sexual partners
Measured: 3 monthly measurements from enrolment to the end of follow up at 12 months
STI and pregnancy incidence at follow up in the peer support group compared to the standard
The number of new STI infections and pregnancies recorded every 3 months in the peer support group compared to the standard.
Having an incident STI (Yes/ No) defined as the first new diagnosis of chlamydia and/ or gonorrhoea (positive urine GeneXpert) in a participant who tested negative for either STI (negative urine GeneXpert) at enrolment.
Having an incident pregnancy (Yes/ No) defined as the first new pregnancy (positive urine βHCG) in a participant who was not pregnant (negative urine βHCG ) at enrolment.
Measured: 3 monthly measurements from enrolment to the end of follow up at 12 months
Condom use with total sexual partners in the past 3 months in the peer support groups compared to the control
Proportion of participants with a specific risk score for reported condom use with total sexual partners in the past 3 months comparing the peer support groups and the control. Risk scores assigned for reported condom use with sexual partners in the past 3 months as follows:
- 1= used condoms always
- 2= used condoms most times
- 3= used condoms sometimes
- 4= did not use condoms at all
Measured: 3 monthly measurements from enrolment to study end at 12 months
The proportion of participants who are not using a modern contraceptive at baseline and take up a modern contraceptive method at any time during the study
Number of participants who take up a modern contraceptive method during the study.
Contraceptive uptake (Yes/ No) defined as a participant who reported not using contraception at enrolment taking up a contraceptive method at any time during the study.
Measured: 3 monthly measurements from enrolment to the end of follow up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start12 Jan 2023
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Virus Research Institute (UVRI), European and Developing Countries Clinical Trials Partnership (EDCTP), Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Yunia Mayanja, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516602
- Sponsor's protocol ID
- RGYM220701
- Acronym
- Peers for PREP
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will follow the MRC/UVRI and LSHTM Unit policies and the General Data Protection Regulation (GDPR). Before data is shared, data sharing agreements will be agreed and signed by the responsible parties ensuring participant confidentiality is kept. All personal data/ identifiers will be anonymized before sharing so that records cannot be linked back to an individual. Data will be shared through protected links and servers and not by emails.
Publications
UNAIDS Fact Sheet, Global HIV Statistics. 2021.
Ministry of Health, Uganda Population-based HIV Impact Assessment (UPHIA) 2016-2017: Final Report. Kampala: Ministry of Health; July, 2019. 2019.
Nanyonjo G, Asiki G, Ssetaala A, Nakaweesa T, Wambuzi M, Nanvubya A, Mpendo J, Okech B, Kitandwe PK, Nielsen L, Nalutaaya A, Welsh S, Bagaya BS, Chinyenze K, Fast P, Price M, Kiwanuka N. Prevalence and correlates of HIV infection among adolescents and young people living in fishing populations along Lake Victoria Fishing Communities in Uganda. Pan Afr Med J. 2020 Nov 2;37:208. doi: 10.11604/pamj.2020.37.208.26124. eCollection 2020.
PubMed 33505576Swahn MH, Culbreth R, Salazar LF, Kasirye R, Seeley J. Prevalence of HIV and Associated Risks of Sex Work among Youth in the Slums of Kampala. AIDS Res Treat. 2016;2016:5360180. doi: 10.1155/2016/5360180. Epub 2016 Apr 28.
PubMed 27239340Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.
PubMed 27959766Nel A, van Niekerk N, Van Baelen B, Malherbe M, Mans W, Carter A, Steytler J, van der Ryst E, Craig C, Louw C, Gwetu T, Mabude Z, Kotze P, Moraba R, Tempelman H, Gill K, Kusemererwa S, Bekker LG, Devlin B, Rosenberg Z; DREAM Study Team. Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study. Lancet HIV. 2021 Feb;8(2):e77-e86. doi: 10.1016/S2352-3018(20)30300-3.
PubMed 33539761Kirby T. Cabotegravir, a new option for PrEP. Lancet Infect Dis. 2020 Jul;20(7):781. doi: 10.1016/S1473-3099(20)30497-7. No abstract available.
PubMed 32592669Moretlwe, S.D., et al., Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: interim results from HPTN 084. Journal of the International AIDS Society
Laher F, Bekker LG, Garrett N, Lazarus EM, Gray GE. Review of preventative HIV vaccine clinical trials in South Africa. Arch Virol. 2020 Nov;165(11):2439-2452. doi: 10.1007/s00705-020-04777-2. Epub 2020 Aug 14.
PubMed 32797338Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
PubMed 22784037Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, Tumwesigye E, Psaros C, Safren SA, Ware NC, Thomas KK, Donnell D, Krows M, Kidoguchi L, Celum C, Bangsberg DR. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10(9):e1001511. doi: 10.1371/journal.pmed.1001511. Epub 2013 Sep 10.
PubMed 24058300Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
PubMed 26598776World Health Organisation, WHO implementation tool for pre-exposure prophylaxis ( PrEP) of HIV infection: module 12: adolescents and young adults. 2018.
Ministry of Health, Consolidated guidelines for the prevention and treatment of HIV and AIDS in Uganda. 2016.
World Health Organisation, WHO recommends the dapivirine vaginal ring as a new choice for HIV prevention for women at substantial risk of HIV infection. 2021.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda
- ClinicalTrials.gov ID
- NCT05516602
- Acronym / sponsor ID
- Peers for PREP / RGYM220701
- Conditions
- HIV-1-infection
- Keywords
- Adolescent Girls and Young Women, Oral PrEP, Peer Support, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- Uganda Virus Research Institute (UVRI), European and Developing Countries Clinical Trials Partnership (EDCTP), Karolinska Institutet
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP.
Main Study Aim:
To evaluate a peer support intervention aimed at improving uptake of and adherence to oral pre-exposure prophylaxis (PrEP), and its effect on sexual behavioral and reproductive health outcomes
Study Objectives:
- To evaluate the effect of a peer support intervention on uptake of and adherence to oral PrEP among 14-24-year-old AGYW at risk of HIV infection in Kampala, Uganda. ii. To evaluate the effect of the peer support intervention aimed at improving oral PrEP uptake and adherence, on sexual behavior and reproductive health outcomes among AGYW in Kampala, Uganda.
Design An individually randomized controlled trial with parallel group design and 1:1 randomization in the intervention and control arms.
Population: 14-24-year old AGYW at risk of HIV infection in Kampala.
Control arm: Standard health worker counselling during clinic visits.
Intervention arm: Standard health worker counselling during clinic visits + peer support groups over the weekend.
Detailed description
1 INTRODUCTION 1.1 Background Adolescent girls and young women (AGYW) aged 15-24 years in Sub-Saharan Africa (SSA) are at substantial risk for HIV infection and in 2020, AGYW accounted for 32% of new HIV infections in East and Southern Africa [1]. In the general population in Uganda, the HIV prevalence among AGYW is estimated at 1.8% among 15-19 year-olds and 5.1% among 20-24 year-olds [2]. The prevalence among AGYW living in fishing communities in Uganda, and young female sex workers (FSWs) is even higher estimated at 15.4% and 22.5% respectively [3, 4]. During recent years, biomedical interventions for HIV prevention have been developed and are currently at different stages of the pipeline with some already approved for use. For example, anti-retroviral (ARV) implants for pre-exposure prophylaxis (PrEP) to protect HIV negative girls from becoming HIV infected, have recently been assessed in pre-clinical studies [5, 6]. Other biomedical interventions for HIV prevention among vulnerable HIV negative sub-groups, including AGYW in SSA, have further been assessed in clinical trials for example: the Dapivirine vaginal ring (DVR) [7, 8], long acting injectable PrEP [9, 10], HIV vaccines [11] and oral PrEP [12, 13]. Oral PrEP is a single pill taken once daily during periods of risk to HIV infection, and is highly efficacious when adherence is good (>90%) [12]. Tenofovir is one of the most common HIV drugs and tenofovir-based oral PrEP is also one of the World Health Organization (WHO) approved biomedical HIV prevention interventions [14, 15]. In 2016, the Uganda government approved use of oral PrEP for HIV prevention among individuals at substantial risk of HIV infection [16], and increased access to targeted key populations including AGYW. The HIV prevention landscape is promising as other novel biomedical HIV prevention interventions are in various stages of development, including long acting injectable PrEP, anti-retroviral (ARV) implants and HIV vaccines. The Dapivirine vaginal ring is approved by WHO as an additional HIV prevention choice for women [17], has been approved for use in South Africa [18] and, has been added to the drug register of the National Drug Authority in Uganda [19]. Injectable cabotegravir may also be available soon having shown efficacy in the HIV Prevention Trials Network (HPTN084) study [10]. End-user preferences for HIV prevention products may predict method uptake [20] and there is a need to increase researchers' knowledge about current preferences for HIV prophylaxis among AGYW in SSA who continue to be at substantial risk of HIV.
1.2 Oral PrEP Uptake and Adherence among Adolescent Girls and Young Women Oral PrEP is still currently the only available biomedical HIV prevention method in most parts of SSA. PrEP implementation projects have been facilitated through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) funding. Despite the potential benefits in HIV prevention, uptake and adherence to oral PrEP remain low among AGYW in Uganda and other parts of SSA [21, 22]. A recent study among AGYW in Kampala, Uganda, with high reported prevalence of being engaged in sex for compensation, also found a low oral PrEP uptake (31%) in this population [23]. The study also found that the uptake was higher in respondents with more sexual partners and among those who showed higher preference for oral PrEP over other biomedical HIV prevention methods when asked at enrolment. Importantly, tests for Tenofovir levels in blood showed very low adherence. Conversely, the Prevention Options for Women Evaluation Research (POWER) project which also enrolled 16-25-year-old AGYW in Kenya and South Africa reported high PrEP uptake (90%) associated with higher risk behavior, intimate partner violence (IPV), depression and chlamydia/ gonorrhea diagnosis [24]. Despite high PrEP uptake, the POWER project reported early discontinuation of PrEP use due to side effects, challenges with accessing services and product characteristics such as need for daily dosing [24, 25]. Other studies have identified pill burden, side effects [21, 22], low risk perception [26, 27] and limited awareness of oral PrEP [28] as barriers to PrEP uptake among AGYW in SSA. Interviews with potential PrEP users in multiple settings in central Uganda also showed that stigma, transport costs to get PrEP refills, accessibility, busy schedules, and forgetfulness were barriers to PrEP uptake while closeness of PrEP providers to one's home was a facilitator [29]. Thus, there is a need for interventions that may promote PrEP use among AGYW populations in SSA who are at increased risk of HIV infection.
1.3 Rationale Peer-to-peer support is one of the strategies proposed for improving HIV prevention and promotion of safer sexual behaviors in the Uganda National HIV research agenda [30], but there is limited evidence of its effectiveness in PrEP programs. Studies show that young people easily take on behaviors when in groups than as individuals, easily adopt behaviors and norms of their peers [31, 32], and are more easily affected by peer influence compared to children and older adults [33]. Among young people living with HIV in Zimbabwe, peer-led psycho-social support services among HIV positive individuals led to a 13% decrease in detectable viremia at 6 months compared with counselling delivered by health care workers (HCWs) [34]. A recent study among refugee adolescents in Northern Uganda showed same day acceptance of contraception was 9% higher among those who received peer counselling compared to counselling provided by HCWs [35]. In addition, trained peers have led to improvements in the HIV care and treatment cascade and contraceptive use through peer counselling, peer support for example delivery of interventions, peer referral etc. [36, 37]. Previous evidence suggests that peer counselling and support interventions have improved HIV testing, utilization of health care services, anti-retroviral therapy (ART) initiation, adherence to treatment, adherence to HIV viral load testing at 6 months and HIV viral suppression among young people living with HIV in Zimbabwe [37, 38]. Peer support interventions may therefore also improve oral PrEP uptake and adherence, and also reduce sexual behavior risk among AGYW, but this has not been widely studied.
- STUDY AIMS AND RESEARCH QUESTIONS 2.1 The main aim of this project is to evaluate the effect of a peer support intervention on oral PrEP uptake and adherence, sexual behavioral and reproductive health outcomes of 14-24-year-old AGYW who are at high risk of HIV infection.
2.2 Research Questions i. What is the effect of a peer support intervention on uptake of and adherence to oral PrEP among AGYW aged 14-24 years at high risk of HIV infection in Uganda? ii. What are the effects of a peer support intervention for oral PrEP uptake and adherence on sexual behavior and reproductive health outcomes of AGYW aged 14-24 years at high risk of HIV infection in Uganda?
The investigators hypothesize that the peer support intervention will: (i) improve oral PrEP uptake and adherence among AGYW; (ii) reduce sexual behavioral risk, pregnancy and sexually transmitted infection (STI) rates
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Support | Experimental | Other: Peer SupportStandard health worker counselling during clinic visits plus peer support over the weekends. |
| Standard | No intervention | –Standard health worker counselling during clinic visits. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- HIV negative (assessed through rapid blood test)
- Sexually active in the past 3 months
- 14-24 years
- Hepatitis B negative for those who initiate oral PrEP
- Willing to undergo study procedures
Key exclusion criteria (6 listed)
- HIV infection
- Currently taking oral PrEP
- Known allergy to common medications, components of oral PrEP or contraceptives
- Pregnant
- An acute or chronic illness that may affect volunteer participation or achieving study objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer SupportPeer-led support groups over the weekend will include the following activities: * Peer leader counselling on oral PrEP and HIV risk reduction * Peer leader discussion to dispel myths and misconceptions around oral PrEP * Peer leader sharing of experiences of daily pill taking * Participants sharing experiences of influencers and barriers to oral PrEP uptake and adherence followed by a discussion by group members. * 1-2 role plays per support group session. | Other | Peer Support |
Primary outcome
The proportion of enrolled participants who take up oral PrEP after randomization to peer support or the standard
Time frame: Measured from enrolment to the end of follow up at 12 months
Number of participants who take up oral PrEP divided by the total number enrolled. PrEP uptake was measured as a participants accepting the offer of oral PrEP and picking their first month's supply from the clinic.
The proportion of volunteers who take up oral PrEP and adhere to oral PrEP after randomization to peer support or the standard
Time frame: 3 monthly measurements from enrolment to the end of follow up at 12 months
Number of participants who adhere to oral PrEP divided by the total number taking oral PrEP. Adherence was measured using self reports, pill counts and rapid urine tenofovir kits
Time in days to oral PrEP uptake from the date it is offered after randomization to peer support or the standard.
Time frame: Measured from enrolment to the end of follow up at 12 months
Number of days from the date a participant is offered oral PrEP to the date they pick the first month's supply from the clinic.
4 secondary outcomes
Total number of sexual partners in the past 3 months in the peer support group compared to the standard
Time frame: 3 monthly measurements from enrolment to the end of follow up at 12 months
STI and pregnancy incidence at follow up in the peer support group compared to the standard
Time frame: 3 monthly measurements from enrolment to the end of follow up at 12 months
Condom use with total sexual partners in the past 3 months in the peer support groups compared to the control
Time frame: 3 monthly measurements from enrolment to study end at 12 months
The proportion of participants who are not using a modern contraceptive at baseline and take up a modern contraceptive method at any time during the study
Time frame: 3 monthly measurements from enrolment to the end of follow up at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- BackgroundUNAIDS Fact Sheet, Global HIV Statistics. 2021.
- BackgroundMinistry of Health, Uganda Population-based HIV Impact Assessment (UPHIA) 2016-2017: Final Report. Kampala: Ministry of Health; July, 2019. 2019.
- Background: PubMed 33505576Nanyonjo G, Asiki G, Ssetaala A, Nakaweesa T, Wambuzi M, Nanvubya A, Mpendo J, Okech B, Kitandwe PK, Nielsen L, Nalutaaya A, Welsh S, Bagaya BS, Chinyenze K, Fast P, Price M, Kiwanuka N. Prevalence and correlates of HIV infection among adolescents and young people living in fishing populations along Lake Victoria Fishing Communities in Uganda. Pan Afr Med J. 2020 Nov 2;37:208. doi: 10.11604/pamj.2020.37.208.26124. eCollection 2020.
- Background: PubMed 27239340Swahn MH, Culbreth R, Salazar LF, Kasirye R, Seeley J. Prevalence of HIV and Associated Risks of Sex Work among Youth in the Slums of Kampala. AIDS Res Treat. 2016;2016:5360180. doi: 10.1155/2016/5360180. Epub 2016 Apr 28.
- Background: PubMed 27959766Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.
- Background: PubMed 33539761Nel A, van Niekerk N, Van Baelen B, Malherbe M, Mans W, Carter A, Steytler J, van der Ryst E, Craig C, Louw C, Gwetu T, Mabude Z, Kotze P, Moraba R, Tempelman H, Gill K, Kusemererwa S, Bekker LG, Devlin B, Rosenberg Z; DREAM Study Team. Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study. Lancet HIV. 2021 Feb;8(2):e77-e86. doi: 10.1016/S2352-3018(20)30300-3.
- Background: PubMed 32592669Kirby T. Cabotegravir, a new option for PrEP. Lancet Infect Dis. 2020 Jul;20(7):781. doi: 10.1016/S1473-3099(20)30497-7. No abstract available.
- BackgroundMoretlwe, S.D., et al., Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: interim results from HPTN 084. Journal of the International AIDS Society
- Background: PubMed 32797338Laher F, Bekker LG, Garrett N, Lazarus EM, Gray GE. Review of preventative HIV vaccine clinical trials in South Africa. Arch Virol. 2020 Nov;165(11):2439-2452. doi: 10.1007/s00705-020-04777-2. Epub 2020 Aug 14.
- Background: PubMed 22784037Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
- Background: PubMed 24058300Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, Tumwesigye E, Psaros C, Safren SA, Ware NC, Thomas KK, Donnell D, Krows M, Kidoguchi L, Celum C, Bangsberg DR. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10(9):e1001511. doi: 10.1371/journal.pmed.1001511. Epub 2013 Sep 10.
- Background: PubMed 26598776Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
- Individual participant dataSharing planned: No. Data sharing will follow the MRC/UVRI and LSHTM Unit policies and the General Data Protection Regulation (GDPR). Before data is shared, data sharing agreements will be agreed and signed by the responsible parties ensuring participant confidentiality is kept. All personal data/ identifiers will be anonymized before sharing so that records cannot be linked back to an individual. Data will be shared through protected links and servers and not by emails.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunia Mayanja principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support in people with HIV-1-infection, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of enrolled participants who take up oral PrEP after randomization to peer support or the standard (time frame: Measured from enrolment to the end of follow up at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516602, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.