NCT02027714|Completed
Enhanced HIV Prevention in Couples: Feasibility Study #1
EPIC
Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
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EPIC
Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
Sponsor study identifier
Secondary identifiers
observational
230
1 country
4
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)The purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn more about men, women and couples in Lesotho and what they think about various topics related to HIV, including HIV testing and counseling, male circumcision and HIV treatment. There will be three parts to the study including 1) a survey 2) focus group discussions; and 3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited to participate in the survey. Women who answer the questionnaire will also be asked to participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be conducted. Thirty men from the community will be recruited to participate in an in-depth individual interview.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 7, 2013
Actual (reported)January 6, 2014
Actual (reported)May 2014
Actual (reported)May 2014
Actual (reported)Percent of pregnant and postpartum women who have been tested for HIV
Using quantitative surveys conducted at the study sites, pregnant and postpartum women within 6 months of delivery will be asked if they have ever been tested for HIV.
6 months
Percentage of index participants that live with their partner
6 months
Percentage of male participants who have been circumcised
6 months
Quantitative surveys will be administered to 200 pregnant and recently postpartum women. Surveys will be conducted in either English or Sesotho depending on the participant's preference. Surveys will be administered by a study-staff member. Survey activities will be conducted in a private space either within or around the clinic building. All study activities will take approximately 1 hour to complete. The survey is comprised of 62 close-ended questions. Included in this survey are questions related to demographics, sexual behaviors, HIV and various HIV testing services.
6-8 focus groups of approximately 6-12 pregnant or recently postpartum women will be conducted. Focus group discussions will be organized according to HIV serostatus to allow for open dialogue and participant comfort. All group discussions will be conducted in Sesotho. Each group discussion will be facilitated, preferably, by a female study-staff member. All group discussions will be held in a private space either within a study site or another specified location within the community. All study activities will take approximately two hours to complete. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding male circumcision will be asked.
30 in-depth individual interviews with men. In-depth semi structured interviews consisting of open-ended questions will be conducted in either English or Sesotho depending on the participant's preference will be conducted. Interview activities will be conducted in a private space either within or around the clinic building. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding traditional and medical male circumcision will be asked. Following the completion of the interview, the same facilitator will administer a brief survey to the study participant.
Pregnant and postpartum women within 6 months of delivery and men will be enrolled. This feasibility study is targeting women seeking care in ANCs as these clinics are where large numbers of women learn their HIV status and become engaged in HIV prevention and/or care and treatment services. It is through these women that men from the community will be recruited for participation in the study.
Le'Coop Health Center
Mafeteng, Lesotho
Mafeteng District Hospital
Mafeteng, Lesotho
Mpharane Clinic
Mohale's Hoek, Lesotho
Ntsekhe Hospital
Mohale's Hoek, Lesotho
Wafaa M El-Sadr, MD/MPH
ICAP-NY, Columbia University
230 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2013
First Posted
January 6, 2014
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
March 24, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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