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Completed

NCT Number: NCT02027441

Enhanced Prevention in Couples: Feasibility Study #2

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.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mafeteng Hospital, Mafeteng, Lesotho

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About this study

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:

  • To evaluate the feasibility and acceptability of home-based testing for HIV testing of partners of index participants
  • To evaluate the effectiveness of home-based partner testing strategies to identify HIV-serodiscordant couples
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Individuals who do not meet the inclusion criteria outlined above
  • Individuals who report being HIV-infected
  • Any condition which in the opinion of the investigators would interfere with participation in the study

Treatment and study plan

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

Other names: SCT

Primary outcomes

  1. Number of partners tested

    Time frame: 12 months

    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.

  2. Number of household members tested

    Time frame: 12 months

    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.

  3. Number of HIV-serodiscordant couples identified

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2

Acronym: EPIC

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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