An observational study in Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), sponsored by Columbia University. Completed at 4 sites in Lesotho. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Columbia University · Observational
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.
Studies to date indicate that HIV negative partners within HIV-discordant couples (where one partner is HIV+ and the other is HIV-) are at substantial risk of acquiring HIV infection and that such transmission may play animportant role in heterosexual transmission of HIV in countries with high seroprevalence in sub-Saharan Africa. The purpose of this study is to conduct preparatory research needed to design and implement an HIV-prevention intervention trial aimed at decreasing the risk for HIV infection among HIV-discordant couples in Lesotho.
Using both quantitative and qualitative research methods, the study aims to:
There will be three study components including 1) quantitative survey 2) focus group discussions; and 3) in-depth individual interviews. A quantitative cross-sectional survey will be administered to 200 pregnant and recently postpartum women. Qualitative components will be based on open-ended iterative inquiry via focus group discussions and in-depth interviews with two groups: (1) pregnant and recently postpartum women; and (2) men. Data gathered during this study will inform the study design and intervention components of the proposed prevention intervention study.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 230 is below the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women's Quantitative Survey
Women's Focus Group Discussion
Male Individual Interviews
Exclusion Criteria:
For all quantitative and qualitative components
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 6 months
Percentage of index participants that live with their partner
To assess the feasibility of home-based testing, we will assess the percentage of pregnant and recently post-partum women that live with their partners.
Time frame: 6 months
Percentage of male participants who have been circumcised
We will ask male participants if they have been circumcised to determine the feasibility and need for MC inclusion in future interventions.
Time frame: 6 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →