Enhanced Prevention in Couples: Feasibility Study #2

NCT02027441 | Completed

• 2 other identifiers: AAAK41015R01AI083038
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Serodiscordant; Lesotho; Home-based testing

Outcome Measures

Primary Outcomes (3)

• Number of partners tested

  Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of partners being tested for HIV, the number of partners tested will be assessed.

  12 months

• Number of household members tested

  Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of household members being tested for HIV, the number of household members tested will be assessed over the course of this study.

  12 months

• Number of HIV-serodiscordant couples identified

  Consistent with the primary study objectives to evaluate the effectiveness of a home-based HIV testing strategy to identify HIV-serodiscordant couples, we will document the number of HIV-serodiscordant couples identified over the course of this study.

  12 months

Study Arms (1)

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.

Other: Standard Counseling and Testing

Interventions

Standard Counseling and Testing 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

Also known as: SCT

Home-based Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women already tested for HIV attending participating antenatal clinics. Men and women already tested for HIV receiving care and treatment at participating TB clinics. This study will recruit women attending ANC and men and women attending TB clinics. All men and women recruited for the study will have already been tested for HIV and received their test results. These facilities were selected as entry points for the study as these clinics are locations where large numbers of individuals are offered HIV testing and become engaged in HIV prevention and/or care and treatment services.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Mafeteng Hospital

Mafeteng, Lesotho

Location

Ntsekhe Hospital

Mohale's Hoek, Lesotho

Location

Biospecimen

Retention: NONE RETAINED

HIV rapid tests will also be conducted using whole blood finger-stick.Blood will be collected specifically for this study. Specimens will not be stored. All rapid HIV test kits will be labeled using a unique participant identification number. Participant names will not be included on the label.

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
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor; Director, ICAP

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: January 6, 2014
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

LE (2)