Identifying Efficient Linkage Strategies for Men

Summary

HIV self-testing (HIVST) has been found to be a highly acceptable approach for men to learn of their HIV status and has resulted in increased testing uptake. However, rates of antiretroviral therapy (ART) initiation among those tested with HIVST are difficult to capture. This clinical trial will test varying approaches to ART initiation and retention among men who test positive using HIVST to learn about the most effective strategy to engage men in ART services.

Conditions

• Hiv

Interventions

OTHER

Male Counseling and Facility Navigation

At enrollment, study staff distribute pamphlet with male-specific messaging and contact information for nearest facility. Low-level cadre traces participants and provides one-on-one, in person male-specific counseling. Meeting at location of participants choice. Follow-up male-specific counseling is offered every 14 days thereafter until 90 days is reached OR 4-week follow-up ART refill visit is completed. Participants who choose to initiate ART are escorted to nearest health facility and provided facility navigation assistance.

OTHER

Home-Based ART Initiation and Facility Navigation

At enrollment, study staff distribute two pamphlets on: 1) male-specific messaging and 2) details about home-based ART initiation. Low-level cadre traces participants and provides one-on-one, in person male-specific counseling, and a detailed description of home-based ART initiation with a nurse. Meeting at the location of participants choice. Follow-up male-specific counseling and information about home-based initiation is offered every 14 days thereafter until 90 days OR 4-week ART follow-up refill visit is complete. Participants who choose to initiate ART at home or in the community will meet with a nurse at a place of the participants choosing. Those who choose to initiate at the facility will receive facility navigation and initiation. All clients will receive a "warm handover" for their 4-week ART follow-up visit.

OTHER

Stepped Intervention

Day 0-14 Arm 1 (Male-specific counseling and facility navigation arm) implemented. Day 14-30, if not yet initiated, a psychosocial counsellor will trace the participant to provide advanced counselling and motivational interviewing. Psychosocial counsellors will act as 'Male Mentors' and meet with men as frequently as needed. Day 30-89 if not yet initiated, nurse-led home-based ART initiation will be offered, following the same steps as listed in the "Home-Based ART Initiation" Arm.

Sponsors & Collaborators

• Partners in Hope, Inc.

  collaborator INDUSTRY

• Boston University

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2025-03-15

Completion

2025-06-15

Countries

• Malawi

Study Locations