Safer Conception Intervention for HIV-1 Serodiscordant Couples

Completed

Conditions studied: HIV Seropositivity, Pregnancy, High-Risk

In brief

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.

Key facts

Study ID

NCT03030768

Run by

University of Washington

People needed

74

Starts

2016-02-01

Expected to finish

2018-07-01

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Couples
• Immediate fertility intention
• Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
• Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
• For HIV-1 infected members of the couple (index participants)
• Able and willing to provide written informed consent
• HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
• Not currently pregnant or breastfeeding
• No use of injectable contraception for the past 3 months
• Not currently enrolled in an HIV-1 treatment study
• No clear indication of infertility or subfertility, as determined by medical history
• Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 uninfected partner
• Know how to send and receive SMS
• Have regular access to electricity or an alternative means for charging a cell phone Literate in English, Kiswahili or Kikuyu
• For HIV-1 uninfected members of the couple (partner participants)
• Able and willing to provide written informed consent
• HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
• Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
• Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
• Not currently pregnant or breastfeeding
• No use of injectable contraception for the past 3 months
• Not currently enrolled in an HIV-1 prevention clinical trial
• Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
• No clear indication of infertility or subfertility, as determined by medical history
• Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 infected partner

You may not qualify if…

• For couples
• Participated in the Partners PrEP Study or the Partners Demonstration Project For HIV-1 infected members of the couple (index participants)
• Currently pregnant or breastfeeding
• Used an injectable contraception in the past 3 months
• Currently enrolled in an HIV-1 treatment study
• Has a clear indication of infertility or sub-fertility, as determined by medical history
• For HIV-1 uninfected members of the couple (partner participants):
• Infected with hepatitis B virus, as determined by a positive hepatitis B surface antigen test
• Currently pregnant or breastfeeding
• Used an injectable contraception in the past 3 months
• Currently enrolled in an HIV-1 prevention clinical trial
• Has a clear indication of infertility or subfertility, as determined by medical history
• Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

Where it is running

• University of Washington, Coordinating Center — Seattle, Washington, United States
• Partners in Health, Research and Development — Thika, Kenya

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.