Enhanced HIV Prevention in Couples: Feasibility Study #1

NCT02027714 | Completed

• 2 other identifiers: AAAF03721R01AI083038-01
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)

Keywords

Discordant; Lesotho; Couples; Enhanced Prevention Package (EPP); ART; Counseling; Male Circumcision

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of index participants that live with their partner

  6 months

• Percentage of male participants who have been circumcised

  6 months

Study Arms (3)

Women's Quantitative Survey

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.

Women's Focus Group Discussions

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.

Male Interviews

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• For all quantitative and qualitative components
• Any condition which in the opinion of the investigators would interfere with adherence to study requirements

Sponsors & Collaborators

• Columbia University: lead

Study Sites (4)

Le'Coop Health Center

Mafeteng, Lesotho

Location

Mafeteng District Hospital

Mafeteng, Lesotho

Location

Mpharane Clinic

Mohale's Hoek, Lesotho

Location

Ntsekhe Hospital

Mohale's Hoek, Lesotho

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Wafaa M El-Sadr, MD/MPH

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, ICAP

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: January 6, 2014
• Study Start: April 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

LE (4)