Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-24
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Peers who are stars
BehavioralA 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Young Mentor Mothers supportExperimental treatment 1 intervention
Group B: Control (Standard of Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 month2
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 months3
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-randomizationSecondary outcomes
1
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-randomization2
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-randomizationOther outcomes
1
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-randomization2
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-randomization3
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-randomization4
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-randomizationSponsors and contacts
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University College, London
Lead sponsor
Centre for Sexual Health and HIV/AIDS Research Zimbabwe
Collaborator
Liverpool School of Tropical Medicine
Collaborator
UK Research and Innovation
Collaborator
Organization for Public Health Interventions and Development
Collaborator
Ministry of Health and Child Welfare, Zimbabwe
Collaborator
Source ClinicalTrials.gov
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