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

NCT04878601 | Unknown DMC

• 1 other identifier: K01TW011484
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[209 females, 261 males\]

Conditions

Hiv

Keywords

HIV; HIV Self-Testing; HIVST; Index HIVST; Index Testing; Men; Male Partners; Antiretroviral therapy; ART initiation; Home-based ART; ART retention

Outcome Measures

Primary Outcomes (1)

• Men's ART Initiation

  ART initiation within 6-months of enrollment. Sourced from medical chart reviews.

  6 months

Secondary Outcomes (1)

• Men's 6-month Retention

  6 months

Study Arms (2)

hbART

EXPERIMENTAL

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

Other: Home-Based ART

fbART

ACTIVE COMPARATOR

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

Other: Facility-Based ART

Interventions

Home-Based ART OTHER

Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided.

hbART

Facility-Based ART OTHER

Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly.

fbART

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• ≥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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Partners in Hope, Inc.: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Partners in Hope

Lilongwe, Malawi

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Multiple Endocrine Neoplasia Type 1

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; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

MA (1)