An interventional study of Peers who are stars in HIV Prevention, Contraceptive Usage and Adherence, Medication, sponsored by University College, London. Not yet recruiting at 3 sites in Zimbabwe. Open to female participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University College, London · Not applicable, Interventional, and Supportive care
This is a pilot cluster-randomized control trial co-led by Dr. Valentina Cambiano, Associate Professor of Epidemiology at University College London, UK and Professor Euphemia Sibanda, Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe). The goal of the proposed study is to evaluate the appropriateness, feasibility, acceptability, uptake, costs and cost-effectiveness of a community-based, HIV-status neutral peer-led service delivery model in which young mentor mothers (YMM) work with pregnant and lactating adolescent girls and young women (PL-AGYW, aged 15-24), up to two-years post-birth, in Zimbabwe to promote uptake of contraception and HIV prevention.
YMM living with HIV have been found to be effective in supporting their peers for prevention of mother-to-child transmission of HIV and adherence to treatment through the "Zvandiri" programme. The investigators propose adapting the "Zvandiri" YMM to include those without HIV to promote behaviour to prevent HIV and unintended pregnancies. This proposed intervention is building on the formative work that had the overall aim of co-developing with AGYW (aged 15-24) a Pre-Exposure Prophylaxis (PrEP) implementation intervention for AGYW who need it, that attracts them to PrEP, and supports pregnant and lactating adolescent girls and young women while taking it.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 600 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Pregnant and lactating adolescent girls and young women in addition to the normal service that they have already been receiving from health facilities in their communities, are supported by young mentor mothers.
Behavioral: Peers who are stars
Pregnant and lactating adolescent girls and young women in the standard of care arm will receive the normal service they have already been receiving from health facilities in their communities. These include antenatal care, delivery and postnatal care covering immunization and child health, family planning and contraception services that are offered at facility level. In addition, the services include facility-delivered offer of HIV prevention and sexual and reproductive health (including HIV testing, offer of Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis and access to antiretroviral treatment for HIV) services. Health facility staff (or designated community health workers) may from time to conduct community visits for education purposes, commodity distribution, follow up of people wh
A community-based HIV status-neutral intervention will be delivered by peers known as young mentor mothers (YMM) who will mobilise uptake of HIV prevention and contraception among pregnant and lactating adolescent girls and young women (PL-AGYW; aged 15-24 years old). Specific YMM roles will include: i) conducting educational home-visits; ii) accompanying the most vulnerable PL-AGYW to clinics; if needed iii) encouragement for HIV testing; iv) distribution of educational materials; v) making referrals/linkages between YMM and existing services for HIV self-testing, Pre-Exposure Prophylaxis, Post-Exposure Prophylaxis, contraception pills and for counselling/support with family/relationship challenges.
Feasibility: YMM who completed the training
Proportion of young mentor mother (YMMs) who agreed to take part in the study that completed the training
Time frame: 1 month
Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW
Proportion of YMM who had contact with at least 20 PL-AGYW with which they had three more conversations (whether face to face, via phone or via message, including Whatsapp)
Time frame: 15 months
Feasibility of extracting effectiveness outcome data
The effectiveness outcome data will be extracted from the paper-registries routinely used in the clinics: PrEP Register, ANC register, Mother Baby Pair register, Family Planning register and HIV Testing Register
Time frame: Study duration (15 months) + 6 months pre-randomization
Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before
Ratio between the average number of PrEP prescriptions (per week; "took PrEP", either initiated or refill) in the last phase of intervention implementation (last 6 months) and before the intervention (6 months preceding the randomization).
Time frame: Study duration (15 months) + 6 months pre-randomization
Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before
Ratio between the average number of modern contraception prescriptions (per week) in the last phase of intervention implementation (last 6 months) and before the intervention (6 months preceding the randomization).
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness PrEP: ratio pre (6 months preceding the randomization) to post (last 6 months of RCT) in the average number of PrEP initiations (per week)
The registry contains the question "Does the client agree to initiate PrEP?"
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness PrEP: Difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of HIV-negative PL-AGYW at risk who received PrEP.
The denominator of the proportion includes only those for which an HIV Testing Services Register line is filled in and in which it is indicated that they are at risk. This is the tool in which it is recorded if they are at risk (de facto eligible for PrEP).
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness PrEP: difference pre (6 months preceding the randomization) to post (last 6 months of cRCT) in the proportion of all HIV-negative PL-AGYW who received PrEP.
The denominator of the proportion includes HIV-negative PL-AGYW for which at least one of the following register was filled in: PrEP Register, HTS Register, ANC register, Mother Baby Pair register, Family Planning register.
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness PrEP: difference pre (6 months preceding the randomization) to post (last 6 months of cRCT) in the proportion of HIV-negative PL-AGYW at risk, not already on PrEP, who initiate PrEP.
The denominator of the proportion includes PL-AGYW for which an HIV Testing Services Register line is filled in and in which it is indicated that they are at risk and for which it is indicated that they were not on PrEP.
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness PrEP: difference pre (6 months preceding the randomization) to post (last 6 months of cRCT) in the proportion of all HIV-negative PL-AGYW, not already on PrEP, who initiate PrEP.
The denominator of the proportion includes HIV-negative PL-AGYW for which at least one of the following register was filled in (PrEP Register, HTS Register, ANC register, Mother Baby Pair register, Family Planning register) and for which it is indicated that they were not on PrEP.
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness Contraception: difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of post-natal AGYW, in which modern contraception is prescribed.
Modern contraception prescriptions are recorded in the Mother Baby Pair Register.
Time frame: Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness Contraception: difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of post-natal AGYW, which collected male and/or female condoms
Time frame: Study duration (15 months) + 6 months pre-randomization
Plan to share: Yes — An anonymized copy of the data collected through this study (transcription of the audio diaries and in-depth interviews, data from the paper registries and the YMM collection tool and costing dataset) will be created to ensure they are suitable for sharing. We plan to make these data accessible to others outside our team 2 years after study completion to allow time to clean the data and produce manuscripts.
Supporting information: Study protocol, Informed consent form
Time frame: 2 years after study completion.
Access criteria: External users will be asked to provide questions that they would like to address using the data. The PI and co-I will make decisions on whether to supply this data. Decisions will be made within four weeks of the request. Requests will only be denied with good reason. Upon being granted permission they will be required to sign documents which specify that use of the data will be restricted to address those questions that have ethical approval.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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