Status:
COMPLETED
Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Kenya Medical Research Institute
Conditions:
HIV Discordant Couples
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
To evaluate the acceptability, feasibility, and efficacy of vaginal insemination as a method of conception in HIV discordant couples (female positive, male negative) desiring pregnancy in Kisumu, Keny...
Detailed Description
In sub-Saharan Africa, HIV is predominantly transmitted via discordant sexual relationships. With the availability of antiretroviral (ARV) medications, individuals infected with HIV can live relativel...
Eligibility Criteria
Inclusion
- HIV discordant couple (female positive, male negative) desiring conception, monogamous relationship (minimum of three month duration), disclosure of HIV status to the sexual partner, women 18-34 years of age, sexually active (at least three encounters per month), expressed ability to consistently use male condoms, and follow the study protocol with respect to study visits and use of vaginal insemination.
Exclusion
- pregnant (at the time of enrollment or run-in-period), women over 35 years of age (decreased fertility ≥ 35 years of age), self reported history of sterilization or infertility by either partner, use of teratogenic medication (e.g. Efavirenz), and clinical stage of HIV/AIDS 3 or 4.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01468753
Start Date
March 1 2012
End Date
February 1 2014
Last Update
May 15 2015
Active Locations (1)
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1
Family AIDS Care and Education Services - Lumumba Health Centre
Kisumu, Kenya