Safer Conception Intervention for HIV-1 Serodiscordant Couples (SCIP)
|ClinicalTrials.gov Identifier: NCT03030768|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 12, 2018
The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships. Such 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. 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, this study pilots 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 include diagnosis and treatment of STIs and male circumcision.
mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans to ease the burden of addressing health problems. This safer conception intervention incorporates mHealth tools to improve couples' experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception. SMS surveys to collect daily information from women about their fertility signs and SMS messages are 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 mobile application is used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, the investigators will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application. Couples with immediate fertility intentions will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika, Kenya.
|Condition or disease||Intervention/treatment|
|HIV Seropositivity Pregnancy, High-Risk||Drug: PrEP Behavioral: Counseling on timed condomless sex, ART and PrEP adherence|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|Official Title:||Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||July 2018|
HIV-1 serodiscordant couples
Couples where one partner is HIV-1 infected and the other is uninfected, who will receive counseling on timed condomless sex, ART and PrEP adherence. The study intervention focuses on ART use by the HIV-1 infected partner, PrEP (Truvada) use by the HIV-1 uninfected partner, and timed condomless sex during the peri-conception period.
An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex during the peri-conception period.
Other Name: Truvada
Behavioral: Counseling on timed condomless sex, ART and PrEP adherence
An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex
- Pregnancy incidence - rate of pregnancy that occurs per 12 months [ Time Frame: 12 months post enrollment ]Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner
- HIV-1 incidence - rate of new HIV infections that occur per 12 months [ Time Frame: 12 months post enrollment ]Rate of new HIV-1 infections among couples
- User feedback about mHealth tools designed to improve patient experience with safer conception [ Time Frame: 12 months post enrollment ]Women's experiences tracking fertility signs through SMS. Couples' and provider's experiences using a clinic-based mobile application that encompasses clinical, laboratory and fertility data to improve patient-provider communication about safer conception readiness
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030768
|United States, Washington|
|University of Washington, Coordinating Center|
|Seattle, Washington, United States, 98104|
|Partners in Health, Research and Development|
|Study Chair:||Renee Heffron, PhD||University of Washington|