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

Study Overview

• Status: Completed
• Conditions: HIV Discordant Couples
• Intervention / Treatment: Procedure: Vaginal Insemination

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Family AIDS Care and Education Services - Lumumba Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the feasibility of vaginal insemination in HIV discordant couples as compared to natural conception.	8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the consistent use of male condoms for the prevention of sexual transmission of HIV.	8 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Conception in HIV Discordant Couples; Reproduction in HIV Discordant Couples; Vaginal Insemination
• Other Study ID Numbers: P30 AIO27763