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
  Purpose

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


Condition Intervention
HIV Discordant Couples
Procedure: Vaginal Insemination

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study: Acceptability, Feasibility and Efficacy of Vaginal Insemination in HIV Discordant Couples (Female Positive, Male Negative) Desiring Conception in Kisumu, Kenya

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468753

Locations
Kenya
Family AIDS Care and Education Services - Lumumba Health Centre
Kisumu, Kenya
Sponsors and Collaborators
University of California, San Francisco
Kenya Medical Research Institute
Investigators
Study Director: Betty Njoroge, MB. ChB, MPH Kenya Medical Research Institute
Study Chair: Craig Cohen, MD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01468753     History of Changes
Other Study ID Numbers: P30 AIO27763
Study First Received: November 7, 2011
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board
Kenya: Kenya Medical Research Institute

Keywords provided by University of California, San Francisco:
Conception in HIV Discordant Couples
Reproduction in HIV Discordant Couples
Vaginal Insemination

ClinicalTrials.gov processed this record on October 23, 2014