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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01468753
First received: November 7, 2011
Last updated: August 23, 2013
Last verified: August 2013

November 7, 2011
August 23, 2013
March 2012
March 2014   (final data collection date for primary outcome measure)
To evaluate the feasibility of vaginal insemination in HIV discordant couples as compared to natural conception. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01468753 on ClinicalTrials.gov Archive Site
To evaluate the consistent use of male condoms for the prevention of sexual transmission of HIV. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya
Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Discordant Couples
Procedure: Vaginal Insemination
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.
Experimental: Vaginal Insemination
Women will perform vaginal insemination during the fertile period of the menstrual cycle with the collected 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: Procedure: Vaginal Insemination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
April 2014
March 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 34 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01468753
P30 AIO27763
No
University of California, San Francisco
University of California, San Francisco
Kenya Medical Research Institute
Study Director: Betty Njoroge, MB. ChB, MPH Kenya Medical Research Institute
Study Chair: Craig Cohen, MD, MPH University of California, San Francisco
University of California, San Francisco
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP