Clinical trial NCT02027441: Enhanced Prevention in Couples: Feasibility Study #2
Official title: Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Keywords: Serodiscordant
Lesotho
Home-based testing
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2014-01-06
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

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

Primary outcomes:
measure: Number of partners tested
timeFrame: 12 months
measure: Number of household members tested
timeFrame: 12 months
measure: Number of HIV-serodiscordant couples identified
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mafeteng
country: Lesotho
facility: Mafeteng Hospital
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: