| Protocol No: | ECCT/18/11/01 | Date of Protocol: | 31-07-2018 |
| Study Title: |
PrEP Implementation for Mothers in Antenatal Care
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| Study Objectives: | a) BROAD OBJECTIVESThe broad objective of this study is to determine the best model for optimized PrEP delivery in pregnancy by using existing highly accessed MCH systems as a platform for efficiently delivering PrEP to pregnant women. b) SPECIFIC OBJECTIVESAIM 1a. In a cluster RCT among HIV-uninfected pregnant women, to compare universal PrEP (offered to all; women self-select PrEP) to targeted PrEP (offered to women with a high risk score incorporating available partner HIV self-test data) for outcomes reflecting the balance of PrEP effectiveness avoiding unnecessary PrEP exposure to women at low or no risk of HIV: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP. · Hypothesis: Because of better matching of PrEP and targeted, specific PrEP counseling, use to HIV risk, targeted PrEP will result in lower HIV incidence and optimized proportion of women on PrEP. AIM 1b. To compare universal versus targeted PrEP arms for proportion of all women on PrEP, proportion of women ‘appropriately’ on PrEP (based on risk factors), PrEP adherence (drug levels), PrEP duration, partners with HIV status, partners on ART, and infant birthweight, preterm birth, and growth curves; to compare infant outcomes in PrEP exposed infants vs. unexposed; and to determine cofactors of maternal HIV incidence overall and stratified by trial arm. · Hypotheses: Targeted PrEP will result in more ‘appropriate’ PrEP use, better adherence, shorter PrEP duration (stop after partner viral suppression), more partners on ART, and similar infant outcomes. AIM 2. To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and in the postpartum period, per incident HIV infection and disability adjusted life year (DALY) averted. · Hypothesis: Targeting PrEP to women at highest risk of HIV acquisition will be more cost-effective than universal PrEP provision. AIM 3. To qualitatively assess barriers and facilitators to adherence, acceptability, feasibility and potential adaptations in all 3 RCT arms at the organizational, provider, and individual woman level. · Hypothesis: Both models will be acceptable to women and providers; organizations will prefer targeted PrEP. |
| Laymans Summary: | Pregnant and breastfeeding women living in areas that are highly affected by HIV are likely to be infected with HIV. Oral pre-exposure prophylaxis is a new method to help in prevention these women from being infected with HIV. It is important to ensure that this drug reaches women who have the most risk for infection and to ensure that the drug is not used among those with minimal risk. By targetting women who are most at risk, we may maximise benefits, minimise potential risks and ensure that the costs are minimal. This study seeks to look at the best way to deliver PrEP among pregnant and postpartum women. |
| Abstract of Study: |
Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner’s HIV status, and have biologic changes or changes in their partner’s sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) may be an attractive strategy for HIV prevention in pregnancy/postpartum; however, it is important to ensure PrEP reaches women who are at risk for acquiring HIV during pregnancy while avoiding unnecessary PrEP use during pregnancy. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. This cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, at least 200 women per clinic, 4000 women overall), will compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal availability of PrEP (and women self-select whether to use) or targeted offer of PrEP (i.e., offer to women identified as high risk through a standardized risk assessment and partner self-testing, and then women identified as high-risk select whether to use). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost-effectiveness.
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