HIV PreventionOntangaNCT07546344
Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe
A study testing Peers who are stars in people with HIV Prevention and Contraceptive Usage, run by University College, London at 3 sites in Zimbabwe.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Contraceptive Usage, Adherence, Medication
- What is being tested?
- Peers who are stars
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesZimbabwe
- Study dates
- Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- either pregnant or have at least one child who is less than 18 months of age at the time of initial engagement
- Aged 15 - 24 years old
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zimbabwe3 sites
Empandeni clinic
Empandeni Mission, Matabeleland South Province
Kudzai Chidhanguro, +263774217614, phlongwane@ophid.co.zw
Mawabeni Clinic
Mawabeni, Matabeleland South Province
Kudzai Chidhanguro, +263774217614, kudzai.chidhanguro@ceshhar.org
Shangani Rural Hospital
Shangani, Insiza
Kudzai Chidhanguro, +263774217614, kudzai.chidhanguro@ceshhar.org
About this study
Official title: Peer-led Service Delivery Model to Increase HIV Prevention and Contraception in Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe: a Pilot Study
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.
- Conditions
- HIV Prevention, Contraceptive Usage, Adherence, Medication
- Being tested
- Peers who are stars
- Medical subject headings
- Contraception Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peers who are starsBehavioural
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Young Mentor Mothers support | Experimental | 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. Receives: Behavioral: Peers who are stars |
| Control (Standard of Care) | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: YMM who completed the training
Proportion of young mentor mother (YMMs) who agreed to take part in the study that completed the training
Measured: 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)
Measured: 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
Measured: Study duration (15 months) + 6 months pre-randomization
Secondary outcomes (2)
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).
Measured: 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).
Measured: Study duration (15 months) + 6 months pre-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe, Liverpool School of Tropical Medicine, UK Research and Innovation, Organization for Public Health Interventions and Development, Ministry of Health and Child Welfare, Zimbabwe
- Responsible party
- Sponsor
- Investigators
- Valentina Cambiano, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546344
- Sponsor's protocol ID
- 8033051
- Other IDs
- MR/Y034015/1
- Acronym
- Ontanga
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Service Delivery Model to Increase HIV Prevention and Contraception in Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe: a Pilot Study
- ClinicalTrials.gov ID
- NCT07546344
- Acronym / sponsor ID
- Ontanga / 8033051
- Conditions
- HIV Prevention, Contraceptive Usage, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe, Liverpool School of Tropical Medicine, UK Research and Innovation, Organization for Public Health Interventions and Development, Ministry of Health and Child Welfare, Zimbabwe
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Mentor Mothers support | Experimental | Behavioral: Peers who are starsPregnant 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. |
| Control (Standard of Care) | No intervention | –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 |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- either pregnant or have at least one child who is less than 18 months of age at the time of initial engagement
- Aged 15 - 24 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peers who are starsA 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. | Behavioural | Young Mentor Mothers support |
Primary outcome
Feasibility: YMM who completed the training
Time frame: 1 month
Proportion of young mentor mother (YMMs) who agreed to take part in the study that completed the training
Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW
Time frame: 15 months
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)
Feasibility of extracting effectiveness outcome data
Time frame: Study duration (15 months) + 6 months pre-randomization
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
2 secondary outcomes
Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before
Time frame: Study duration (15 months) + 6 months pre-randomization
Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before
Time frame: Study duration (15 months) + 6 months pre-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: 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.
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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.
Valentina Cambiano, PhD principal investigator
University College, London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peers who are stars in people with HIV Prevention and Contraceptive Usage, run by University College, London at 3 sites in Zimbabwe.
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 2 inclusion and 0 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zimbabwe. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kudzai Chidhanguro, MSc (+263774217614, kudzai.chidhanguro@ceshhar.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: YMM who completed the training (time frame: 1 month). 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?
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 22 Apr 2026.