Enhanced Prevention in Couples: Feasibility Study #2

NCT ID: NCT02027441

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 191 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to gather information needed to develop a large prevention trial to decrease risk for Human immunodeficiency virus (HIV) transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho.

The protocol team would like to explore new strategies for increasing the number of partners who receive an HIV test and whether this increase in testing also results in identifying HIV-discordant couples. These couples would be the focus of the future large prevention trial therefore it is critical that the protocol team explore effective strategies for identifying and recruiting these couples.

Men and women (index participants) who are attending antenatal (ANC) and Tuberculosis (TB) clinics will be recruited for this study. If they agree to take part, a testing team will visit their household and offer all adults staying in the house the opportunity to receive an HIV test.

Three hundred index participants will be enrolled into the study and have their homes visited by the testing team. The number of household members tested will depend on the number of people living in each household.

Detailed Description

In Lesotho, a country with estimated 16% discordance among heterosexual couples, reaching male partners and couples in order to engage them in HIV testing to enable identification of discordant couples is an important first step for any HIV prevention and treatment efforts.

This is a feasibility study of the use of home-based HIV testing of partners and household members of individuals recruited from select ANC and TB clinics in Lesotho. This study uses an observational design to evaluate the feasibility and acceptability of home-based testing for HIV testing of partners and the effectiveness of this intervention to identify HIV discordant couples. It is hypothesized that a home-based testing intervention will increase the number of partners testing for HIV and will result in increased identification of newly-diagnosed HIV-discordant couples, the target population of the planned Enhanced Prevention in Couples (EPIC) study.

Primary objectives of this study include:

1. To evaluate the feasibility and acceptability of home-based testing for HIV testing of partners of index participants

2. To evaluate the effectiveness of home-based partner testing strategies to identify HIV-serodiscordant couples

3. To evaluate the feasibility and acceptability of home-based testing for HIV testing of other household members of index participants Three-hundred men and women (index participants) will be recruited from antenatal and TB clinics. HIV testing teams will visit index participant households and offer home-based HIV testing to all adult household members.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Home-based Testing

At enrollment, consenting index participants will provide the study staff with locator information and a complete list of individuals currently living in his/her home who may be eligible for home-based HIV testing intervention (Household Composition form).

The study staff and index participant will schedule a date/time for the study staffto visit the index participant's home. Study staff will also provide the index participant with an information sheet to give to household members.

A study testing team comprised of trained counselors and interviewers will visit the index participant's home on the pre-determined date/time and offer home-based HIV testing to those household members who are present.

Standard Counseling and Testing

Intervention Type: OTHER

Individuals who opt for standard counseling and testing will complete the following procedures:

• Standardized pre- and post-test counseling and HIV testing using HIV rapid test per approved national guidelines

Interventions

Standard Counseling and Testing

Individuals who opt for standard counseling and testing will complete the following procedures:

• Standardized pre- and post-test counseling and HIV testing using HIV rapid test per approved national guidelines

Intervention Type: OTHER

Other Intervention Names

SCT

Eligibility Criteria

Inclusion Criteria

Index Participant

• Women and men at least 18 years of age
• Known HIV status

• For pregnant and post-natal women recruited from the ANC: must have tested for HIV during their current or most recent pregnancy
• For men and women recruited from TB clinic: must have tested in the last 3 months
• Receiving antenatal care or TB care/treatment at participating clinics o For men and women recruited from TB clinic: must have been on TB medications for at least 8 weeks
• Married or living with partner as if married

• Spouse must be a current member of index participant's household (i.e. married or living with the index participant, and currently residing in Lesotho)
• Willing to allow study team to visit home and offer HIV counseling and testing to partner and other household members
• Ability to speak English or Sesotho
• Willing and able to provide signed informed consent

Household Members

• A household member is defined as an individual who:

o Has been sharing a physical structure such as a compound or homestead with the index participant and who has been consuming or making some contribution to food and other shared household resources

Guests who stayed at the household the night before will also be offered participation

• Women and men at least 18 years of age
• Ability to speak English or Sesotho
• Willing and able to provide signed informed consent

• Individuals who report being HIV-infected
• Any condition which in the opinion of the investigators would interfere with participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Wafaa Mahmoud El-Sadr

University Professor; Director, ICAP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wafaa M El-Sadr, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

ICAP-NY, Columbia University

Locations

Mafeteng Hospital

Mafeteng, , Lesotho

Ntsekhe Hospital

Mohale's Hoek, , Lesotho

Countries

Lesotho

Other Identifiers

5R01AI083038

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAK4101

Identifier Type: -

Identifier Source: org_study_id