Identifying Efficient Linkage Strategies for Men
IDEaL
1 other identifier
interventional
569
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Sep 2021
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2025
CompletedJuly 6, 2023
July 1, 2023
3.5 years
May 28, 2021
July 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of men who are retained on ART early
Proportion of men who initiate ART at 3-months and attended their 4-week ART refill appointment at 4-month after enrollment. Sourced from medical chart reviews.
4-months.
Secondary Outcomes (2)
Proportion of men who initiate ART
3-months
Any adverse events self-reported by female ART client or male partner
4-months
Study Arms (3)
Male-specific counseling and facility navigation
EXPERIMENTALHome-Based ART Initiation
EXPERIMENTALStepped Intervention
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- \<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)
- Female partner
- ≥15 years of age
- Male partner enrolled in the study
- Male partner agrees that the female can be recruited for an in-depth interview
- \<15 years of age
- Male partner is not enrolled in the study
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- Partners in Hope, Inc.collaborator
- Boston Universitycollaborator
- Malawi-Liverpool-Wellcome Trust Clinical Research Programmecollaborator
- Charles University, Czech Republiccollaborator
- Bill and Melinda Gates Foundationcollaborator
Study Sites (1)
Partners in Hope
Lilongwe, Malawi
Related Publications (3)
Hubbard J, Mphande M, Robson I, Balakasi K, Phiri K, Chikuse E, Thorp M, Phiri S, Choko AT, Cornell M, Coates T, Dovel K. Core components of male-specific person-centred HIV care: a qualitative analysis from client and healthcare worker perspectives in Malawi. BMJ Public Health. 2024 Dec 22;2(2):e001100. doi: 10.1136/bmjph-2024-001100. eCollection 2024 Dec.
PMID: 40018627DERIVEDHolland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko A. Implementation of Male-Specific Motivational Interviewing in Malawi: An Assessment of Intervention Fidelity and Barriers to Scale-Up. medRxiv [Preprint]. 2024 Sep 26:2024.09.24.24314326. doi: 10.1101/2024.09.24.24314326.
PMID: 39399024DERIVEDDovel K, Balakasi K, Hubbard J, Phiri K, Nichols BE, Coates TJ, Kulich M, Chikuse E, Phiri S, Long LC, Hoffman RM, Choko AT. Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial. BMJ Open. 2023 Jul 12;13(7):e070896. doi: 10.1136/bmjopen-2022-070896.
PMID: 37438067DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 28, 2021
First Posted
November 30, 2021
Study Start
September 1, 2021
Primary Completion
March 15, 2025
Study Completion
June 15, 2025
Last Updated
July 6, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning three months and ending five years following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal. Proposals should be sent to Dr. Dovel (kdovel@mednet.ucla.edu). To gain access, data requestors will need to sign a data access agreement. Data are available for five years.
Individual participant data that underlie the results reported in an article after deidentification (text, tables, figures and appendices).