Adherence, Medication, Contraceptive Usage, HIV Prevention
Conditions
Brief 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). 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.
Interventions
BEHAVIORALPeers who are stars
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.
Sponsors
University College, London
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: YMM who completed the training | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before | Study duration (15 months) + 6 months pre-randomization | 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). |
| Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before | Study duration (15 months) + 6 months pre-randomization | 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). |
Countries
Zimbabwe
Contacts
CONTACTKudzai Chidhanguro, MSc
CONTACTValentina Cambiano, PhD
PRINCIPAL_INVESTIGATORValentina Cambiano, PhD
University College, London
Outcome results
None listed