Clinical trial NCT02027714: Enhanced HIV Prevention in Couples: Feasibility Study #1
Official title: Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Keywords: Discordant
Lesotho
Couples
Enhanced Prevention Package (EPP)
ART
Counseling
Male Circumcision
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of pregnant and postpartum women who have been tested for HIV
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of index participants that live with their partner
timeFrame: 6 months
measure: Percentage of male participants who have been circumcised
timeFrame: 6 months
Other outcomes:
Locations:
city: Mafeteng
country: Lesotho
facility: Le'Coop Health Center
city: Mafeteng
country: Lesotho
facility: Mafeteng District Hospital
city: Mohale's Hoek
country: Lesotho
facility: Mpharane Clinic
city: Mohale's Hoek
country: Lesotho
facility: Ntsekhe Hospital
Study officials:
affiliation: ICAP-NY, Columbia University
name: Wafaa M El-Sadr, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: