Clinical trial NCT01468753: Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya
Official title: Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Discordant Couples
Keywords: Conception in HIV Discordant Couples
Reproduction in HIV Discordant Couples
Vaginal Insemination
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2011-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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, Kenya

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 relatively normal productive lives. Societal and cultural expectations as well as personal reproductive intentions drive HIV positive women in discordant relationships to conceive. Approximately 50% of HIV infected couples desire children. However, a safe and effective method of conception that minimizes the risk of sexual HIV transmission in HIV discordant couples with a positive woman and negative man has yet to be examined. To date, published studies have evaluated assisted reproductive methods in HIV discordant couples with a positive man to decrease the risk of HIV transmission. The investigators intend to evaluate the acceptability, feasibility and efficacy of vaginal insemination with semen for conception in HIV discordant (female positive, male negative) relationships in Kenya. In this pilot study, HIV discordant couples (female positive, male negative) desiring pregnancy will receive targeted reproductive counseling through the Safer and Healthy Conception Program for 6 months. This program will emphasize the consistent use of male condoms and teach couples assisted vaginal insemination for conception to minimize the risk of sexual HIV transmission.The investigators will compare the frequency of male condom use before and after intervention with an audio computer-assisted self-interview validated by random measurement of prostate specific antigen of vaginal secretions. The incidence of pregnancy following vaginal insemination will also be measured. The investigators hypothesize that our findings will provide evidence to support the routine use of vaginal insemination as a safe method of conception in HIV discordant couples (female positive, male negative). This pilot study is of significant public health importance because the use of vaginal insemination for conception in HIV discordant couples (female positive, male negative) is expected to reduce the likelihood of riskier sexual practices for childbearing and decrease the incidence of HIV in Sub-Saharan Africa.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: To evaluate the feasibility of vaginal insemination in HIV discordant couples as compared to natural conception.
timeFrame: 8 months
Secondary outcomes:
measure: To evaluate the consistent use of male condoms for the prevention of sexual transmission of HIV.
timeFrame: 8 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Family AIDS Care and Education Services - Lumumba Health Centre
Study officials:
affiliation: Kenya Medical Research Institute
name: Betty Njoroge, MB. ChB, MPH
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Craig Cohen, MD, MPH
role: STUDY_CHAIR
References: