Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi

University of California, Los Angeles (UCLA)

Status: Active, not recruiting

Conditions: Hiv

Treatments: Other: Facility-Based ART; Other: Home-Based ART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04878601

K01TW011484 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIV self-testing (HIVST). We will pilot an intervention that provides home-based ART initiation and home-based continuation for 3-months, followed by assisted linkage to facility-based care at 4-months. 470 participants will be enrolled [209 females, 261 males]

Full description

Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Achieving epidemic control requires immediate, concentrated effort to engage this largely unreached population. Index partner testing, whereby partners of HIV-positive clients are refereed for HIV testing, is critical to identifying undiagnosed men and has been adopted as a national policy by the Malawi Ministry of Health because of its high acceptability and its dramatic increase on HIV testing uptake. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIVST. We will pilot an intervention that provides home-based ART initiation and home-based continuation for male partners identified as HIV-positive through Index HIVST for 3-months, followed by assisted linkage to facility-based care at 4-months. This intervention offers opt-out ART and in-depth, male-specific counseling for 3-months before linking men to facility based care. We will directly compare home-based ART to facility-based ART, whereby a health care worker will conduct a home-visit with HIV+ male partners to provide confirmatory HIV testing and immediate assisted linkage to a nearby facility for facility-based ART initiation and continuation.

Enrollment: 470 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Female Partner Inclusion Criteria:

• Male partner ≥15 years of age

• No reported interpersonal violence (IPV) as defined by World Health Organization (WHO) with the above male partner in the past 12-months

• Male partner ever tested HIV-positive

• Male partner not currently engaged in ART services, defined as:

  • Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV- positive;
  • ≥14 days late for the first four-week follow up appointment; or
  • Initiated ART but ≥60 days late for last ART appointment;
  • Male partner living inside the facility catchment area (defined as any area that Healthcare Workers (HCWs) from the study facility routinely visit for tracing purposes)

Female Partner Exclusion Criteria:

• Male partner <15 years of age

• Reported interpersonal violence (IPV) as defined by WHO with the above male partner in the past 12-months

• Male partner never tested HIV positive

• Male partner tested HIV-positive <14 days ago

• Male partner currently engaged in ART services, defined as:

  • Initiated ART <14 days late for the first four-week follow up appointment
  • Initiated ART and <60 days late for last ART appointment
  • Male partner living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Men Living with HIV Inclusion Criteria:

• ≥15 years of age

• Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)

• Not currently engaged in ART services, defined as:

  • Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV-positive;
  • ≥14 days late for the first four-week follow up appointment; or
  • Initiated ART but ≥60 days late for last ART appointment;
  • Has not taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
  • Living inside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Men Living with HIV Exclusion Criteria:

• <15 years of age

• Never tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)

• Tested HIV-positive <14 days ago

• Currently engaged in ART services, defined as:

  • Initiated ART
  • <14 days late for the first four-week follow up appointment
  • Initiated ART and <60 days late for last ART appointment
  • Has taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
  • Living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

hbART

Experimental group

Description:

Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months.

Treatment:

Other: Home-Based ART

fbART

Active Comparator group

Description:

Facility-Based ART initiation and continuation with male-specific counseling.

Treatment:

Other: Facility-Based ART