Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya
Condition: HIV Discordant Couples
Study type: Interventional

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.
    

Intervention name(s): Vaginal Insemination
Intervention type(s): Procedure
Intervention description(s): Women will perform vaginal insemination during the fertile period with semen within one hour of collection. Vaginal insemination will occur within one hour of collection 2 days prior to ovulation, on the day of ovulation and 2 days after ovulation for up to 6 months or until conception occurs. For example, if ovulation were on day 14 of a 28 day menstrual cycle, vaginal insemination will occur on days 12, 14 and 16 of the cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Conception in HIV Discordant Couples; Reproduction in HIV Discordant Couples; Vaginal Insemination