| Protocol No: | ECCT/21/09/02 | Date of Protocol: | 11-06-2021 |
| Study Title: | Piloting HIV Pre-exposure Prophylaxis (PrEP) Integration into Services for Early Pregnancy Loss |
| Study Objectives: | Building on prior PrEP programs in Kenya focused on AGYW and our work with clinics providing PAC, this project will advance our understanding of how to optimize delivery of PrEP to AGYW through PAC care and long-term family planning and reproductive health care.Objectives:
a) uptake of PrEP and FP at the PAC site b) linkage of women from PAC to follow-on PrEP and FP services c) retention in PrEP and FP programs d) continuation of PrEP and FP during a 6 month period Approach: We will support approximately 14 PAC facilities to launch PrEP delivery using standard Kenya MOH approaches and tools. After 12 months of delivery, we will use programmatic data that are abstracted from MOH PrEP client encounter cards and FP client cards to estimate PrEP uptake, linkage, retention, and continuation among approximately 2,000 women in Kisumu, Nairobi, Murang’a, Thika and their environs who are accessing PAC.
Approach: Approximately 3 months after all facilities have launched a foundational PrEP program, we will use a randomization process to assign half of the collaborating PAC facilities to launch enhanced adherence support activities with AGYW accessing PrEP (intervention facilities) and half to maintain the foundational program (control facilities that will not add enhanced adherence support activities). After 9 months of both programs, we will compare PrEP continuation between AGYW accessing PrEP in intervention versus control facilities. In a subset of AGYW engaged for research procedures (N=400), we will objectively measure PrEP adherence and compare adherence between women accessing PrEP through intervention versus control facilities and we will conduct qualitative research to understand key factors influencing PrEP adherence.
Approach: We will conduct qualitative research with implementing partners, providers, and clients to understand acceptability, satisfaction, facilitators, and barriers to initiating and sustaining PrEP delivery within PAC.
Approach: In a subset of AGYW engaged for research procedures (N=400), we will use standardized questionnaires to collect demographic, social, clinical and behavioural information and use these data in statistical models of factors associated with PrEP and FP use/non-use. We will also conduct qualitative research to better understand the reasons that compel young women to continue and discontinue PrEP and family planning.
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| Laymans Summary: | Adolescent girls and young women (AGYW) receiving care following a pregnancy loss – whether from a spontaneous miscarriage or induced abortion - are extremely vulnerable to ongoing sexual and HIV risk because of infrequent condom use, recent sexual debut, and experiences with psychosocial distress, stigma, and violence that often characterize their recent past. Results from prior formative work showed that AGYW accessing services from PAC clinics were at a high risk for HIV infection and willing to initiate PrEP alongside PAC services but would only access refills from outside of these clinics (e.g. at family planning clinics). Accessing these women through post-abortal care (PAC) clinics provides an entry point to engage women in HIV prevention, specifically oral PrEP, because of the HIV risk they face. Through the proposed study, we will assess the feasibility and impact of using PAC services in both private and public facilities as an entry point to link AGYW to PrEP, as well as integrated PrEP and contraceptive services in Thika, Nairobi, and Kisumu. The project will enroll up to 2000 AGYW 15-30 years on PrEP from whom 400 AGYW will be enrolled for research activities with 6 months follow-up. These include quantitative and qualitative evaluation of PrEP uptake, linkage to follow-on services and adherence through enhanced adherence support and urine testing of PrEP drug levels. We aim to demonstrate new models of integrating de-medicalised HIV and pregnancy prevention services since it is central to our goal of making services as responsive and accessible to women of reproductive age. Further, gain insights on the AGYW behaviour which determines PrEP uptake and adherence.This project will result in recommendations for how to optimize and scale-up the delivery of HIV prevention services including PrEP as part of PAC care in Kenya and similar settings. |
| Abstract of Study: |
Adolescent girls and young women (AGYW) in Kenya face parallel epidemics for unintended pregnancy and HIV. Existing reproductive health and family planning programs are acceptable and effective entry points to reach AGYW with comprehensive services to prevent these events. AGYW seeking care for an early pregnancy loss- whether from a spontaneous miscarriage or induced abortion- face these epidemics and integrating HIV prevention services, particularly daily oral PrEP, into PAC services is an opportune method to reach them. PrEP is widely available in Kenya for people with substantial risk for HIV. Prior formative work by the protocol investigators found that young women accessing PAC had characteristics (existing STI infection and sexual behavior) that render them susceptible to HIV acquisition. More than half of the women indicated willingness to use PrEP. An additional important finding from the study was that PrEP screening and initiation could be integrated into services provided through the PAC clinic and follow-up for PrEP refills conducted outside of these clinics (e.g. family planning-FP- clinics).
Through the proposed work, we plan to pilot PrEP integration into PAC services among 14 health facilities (public and private) providing PAC to AGYW in Thika, Nairobi, Murang’a, Kisumu and their environs. The project will enroll 2000 AGYW accessing PAC services and engage a subset of 400 for research procedures to evaluate: 1) uptake, adherence, and continuation of PrEP and FP 2) linkage and follow-up on PrEP and FP services 3) impact of enhanced adherence support on PrEP continuation and adherence 4) experiences of young women and providers with an integrated PrEP program, and 5) factors associated with adherence to PrEP and FP. Specifically, we hope that the work will result in robust recommendations for how to optimize and advance long-standing delivery of HIV prevention as part of PAC services in Kenya and similar settings. |