Protocol No: ECCT/21/09/06 Date of Protocol: 15-07-2021

Study Title:

PILOTING HIV PRE-EXPOSURE PROPHYLAXIS (PREP) INTEGRATION INTO SERVICES FOR EARLY PREGNANCY LOSS

Study Objectives:
  1. Among women accessing post-abortal care (PAC) services in Kenya, we will use methods from implementation science to evaluate feasibility of integrating PrEP into PAC services by estimating: 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

  2. To determine the effect of enhanced adherence activities on PrEP continuation and adherence
  3. To qualitatively evaluate the feasibility of integrating PrEP into PAC services and experiences of young women and providers with an integrated PrEP program
  4. To determine factors associated with adherence to PrEP and FP

 

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. This project will result in recommendations for how to optimize and advance the delivery of HIV prevention services 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, and Kisumu. 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.