Enhanced HIV Prevention in Couples: Feasibility Study #1

Human Immunodeficiency Virus (HIV) Clinical Trial

— EPIC  

Official title:

Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027714
• Other study ID #: AAAF0372
• Secondary ID: 1R01AI083038-01
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: March 23, 2015
• Start date: April 2011
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• Establish baseline characteristics of the proposed study population, specifically pregnant and recently postpartum women and of men in Lesotho

• Explore the types of sexual and social relationships that exist between men and women in Lesotho

• Assess individual knowledge, understanding and perceptions around different HIV prevention strategies, including HIV testing and treatment, couples counseling and male circumcision

• Identify interpersonal and individual-level barriers to accessing these types of HIV prevention interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Women's Quantitative Survey

• Women at least 18 years of age

• Pregnant or within 6 months postpartum

• Receiving antenatal care at target clinic

• Ability to speak English or Sesotho

Women's Focus Group Discussion

• All inclusion criteria listed in Women's Quantitative Survey AND

• Ability to speak Sesotho, specifically

• Willingness to disclose HIV status within FGD

• Willingness to allow audio- recording of FGD

Male Individual Interviews

• Men between 18 and 50 years of age

• Living or working in one of the two targeted districts

• Ability to speak Sesotho

• Willingness to allow audio- recording of interview

Exclusion Criteria:

• Individuals meeting any of the exclusion criteria will be excluded from study participation.

For all quantitative and qualitative components

• Individuals who do not meet the inclusion criteria outlined above

• Any condition which in the opinion of the investigators would interfere with adherence to study requirements

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome (AIDS)
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Lesotho	Le'Coop Health Center	Mafeteng
Lesotho	Mafeteng District Hospital	Mafeteng
Lesotho	Mpharane Clinic	Mohale's Hoek
Lesotho	Ntsekhe Hospital	Mohale's Hoek

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No