Protocol No: ECCT/15/10/03 Date of Protocol: 08-09-2015

Study Title:

Pilot of an mHealth-enhanced, safer conception intervention to reduce HIV-1 risk among Kenyan HIV-1 serodiscordant couples

Safer Conception Intervention for Partners (SCIP)


Study Objectives:
Laymans Summary:
Abstract of Study:

The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.

Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions  for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, we will pilot a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex.  Additional strategies for couples will include diagnosis and treatment of STIs and male circumcision. The Figure below presents a schematic of the safer conception components that will be incorporated.

mHealth tools, including SMS and tablet applications, are novel and very popular among Kenyans to ease the burden of addressing health problems.  Our safer conception intervention will incorporate mHealth tools to improve couples’ experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception.  An SMS survey will be used to collect daily information from women about their fertility signs and SMS messages will be used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic tablet application will be used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application.

This work will take place at the Partners in Health Research and Development site in Thika, Kenya, where the clinical research staff are experts in working with HIV-1 serodiscordant couples since the site inception in 2006.  Couples with immediate fertility intentions and a high likelihood to become pregnant within one year – determined by using a validated, empiric scoring tool that we have developed – will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence.  This is the exact outcome that HIV-1 prevention programs need to monitor to ensure that we fully understand the preferences and willingness of couples to practice safer conception and the ability of an integrated intervention to reduce HIV-1 transmission risk to the lowest level possible during peri-conception periods.