Pediatric Enhanced Surveillance Study
NCT02043769
Acquired Immune Deficiency Syndrome (AIDS), Acquired Immunodeficiency Syndrome
East London, Amathole, South Africa
View Trial DetailsNCT Number: NCT02027714
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.
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Notify Me18 year–50 year
All sexes
Observational
Le'Coop Health Center, Mafeteng, Lesotho
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women's Quantitative Survey
Women's Focus Group Discussion
Male Individual Interviews
Exclusion criteria
For all quantitative and qualitative components
Time frame: 6 months
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
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
We will ask male participants if they have been circumcised to determine the feasibility and need for MC inclusion in future interventions.
Columbia University
Other
Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
Acronym: EPIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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