HivIDEaLNCT05137210
Identifying Efficient Linkage Strategies for Men
A study testing Male Counseling and Facility Navigation, Home-Based ART Initiation and Facility Navigation and Stepped Intervention in people with Hiv, run by University of California, Los Angeles at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Male Counseling and Facility Navigation, Home-Based ART Initiation and Facility Navigation and Stepped Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Sep 2021to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥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;
Show all 11Show fewer
- 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)
- ≥15 years of age
- Male partner enrolled in the study
- Male partner agrees that the female can be recruited for an in-depth interview
Who cannot join
- <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
Show all 13Show fewer
- 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 is not enrolled in the study
- Male partner does not agree that the female can be recruited for an in-depth interview
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 and some studies have suggested that linkage rates are low , particularly amongst men. The investigators propose a clinical trial to test varying approaches to ART initiation and retention among men who test HIV-positive through HIVST. Three interventions will be tested:
Standard of Care (Arm 1): phone and in-person follow-up, accompanied with male-specific counseling (given every two weeks for up to 90-days or until ART initiation is achieved, whichever comes first); Home-Based ART initiation (Arm 2): nurse-led ART initiation at home or in the community Staged Intervention (Arm 3): a staged intervention that consecutively increases in intensity every month that a participant does not initiate ART (intervals include: Days 1-14: Standard of Care; Days 14-30: Peer support with a psychosocial consellor; Days 30-90: Nurse-led Home-Based ART initiation);
The primary objective is to identify a cost-effective package comprised of male-specific counseling, peer support, community ART distribution and/or home-based ART services for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. The specific objectives are:
Aim 1. Evaluate the effectiveness of the Stepped ART Intervention (Arm 3) vs male counseling and facility navigation (Arm 1) (primary analysis) and the effectiveness of the Stepped ART Intervention (Arm 3) vs home-based ART initiation with a nurse (Arm 2) (secondary analysis) on ART initiation within 4-months after enrollment in the trial.
Aim 2. Identify individual-, community-, and facility-level factors associated with ART initiation within each intervention arm (male counseling, home-based ART and Stepped intervention) using baseline and semi-structured in-depth interviews.
Aim 3. Determine the cost-effectiveness and scalability of the intervention arms through costing and mathematical modeling.
An individually randomized control trial will be performed with 545 HIV-positive men. Men will be individually randomized 1:1:1 to one of the three intervention arms described above. They will receive their assigned intervention over the course of three months or until the participant initiates ART. The study will be preformed at 10 health facilities supported by Partners in Hope (PIH). Data collection will include baseline and follow-up surveys at 2- and 4-months; medical charter reviews at 2- and 4-months after study enrollment; qualitative interviews with a subset of men and their female partners; and a cost analysis of costs associated with each arm. Male participants will be enrolled in the study for a total of 4 months.
The investigators anticipate learning about the most effective stragty to engage men in ART. The investigators also anticipate learning about the type and degree of followup necessary to support men's engagement in ART services. Finally, the investigators anticipate learning about the cost-effectiveness of intervention, with the goal of improving cost-effectiveness for the Ministry of Health. Results from this study could be used to define best practices and to further scale ART-focused programs for men in Malawi.
- Conditions
- Hiv
- Being tested
- Male Counseling and Facility Navigation, Home-Based ART Initiation and Facility Navigation, Stepped Intervention
- Keywords
- HIV self-testing (HIVST), HIV, Antiretroviral therapy (ART), ART Initiation, ART Retention, Men, HIVST
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male Counseling and Facility NavigationOther
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.
Home-Based ART Initiation and Facility NavigationOther
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.
Stepped InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Male-specific counseling and facility navigation | Experimental | Not described Receives: Other: Male Counseling and Facility Navigation |
| Home-Based ART Initiation | Experimental | Not described Receives: Other: Home-Based ART Initiation and Facility Navigation |
| Stepped Intervention | Experimental | Not described Receives: Other: Stepped Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-months.
Secondary outcomes (2)
Proportion of men who initiate ART
Proportion of men who initiate at 3-months after enrollment. Sourced from medical chart reviews.
Measured: 3-months
Any adverse events self-reported by female ART client or male partner
Self-report of any adverse event from female ART client (IPV, unwanted disclosure, end of relationship) and their male partners (unwanted disclosure) who were identified as HIV-positive. Sourced from follow-up surveys.
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Sep 2021
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Hope, Inc., Boston University, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Charles University, Czech Republic, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Kathryn L. Dovel, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137210
- Sponsor's protocol ID
- INV-001423
- Other IDs
- INV-001423
- Acronym
- IDEaL
- Status last verified
- Jul 2023
- First submitted
- 28 May 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in an article after deidentification (text, tables, figures and appendices).
Publications
Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko AT. Implementation of male-specific motivational interviewing in Malawi: an assessment of intervention fidelity and barriers to scale-up. BMJ Glob Health. 2026 Mar 31;11(3):e018269. doi: 10.1136/bmjgh-2024-018269.
PubMed 41916615Hubbard 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.
PubMed 40018627Holland 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.
PubMed 39399024Dovel 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.
PubMed 37438067
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Efficient Linkage Strategies for Men
- ClinicalTrials.gov ID
- NCT05137210
- Acronym / sponsor ID
- IDEaL / INV-001423
- Conditions
- Hiv
- Keywords
- HIV self-testing (HIVST), HIV, Antiretroviral therapy (ART), ART Initiation, ART Retention, Men, HIVST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 569 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Partners in Hope, Inc., Boston University, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Charles University, Czech Republic, Bill and Melinda Gates Foundation
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 and some studies have suggested that linkage rates are low , particularly amongst men. The investigators propose a clinical trial to test varying approaches to ART initiation and retention among men who test HIV-positive through HIVST. Three interventions will be tested:
Standard of Care (Arm 1): phone and in-person follow-up, accompanied with male-specific counseling (given every two weeks for up to 90-days or until ART initiation is achieved, whichever comes first); Home-Based ART initiation (Arm 2): nurse-led ART initiation at home or in the community Staged Intervention (Arm 3): a staged intervention that consecutively increases in intensity every month that a participant does not initiate ART (intervals include: Days 1-14: Standard of Care; Days 14-30: Peer support with a psychosocial consellor; Days 30-90: Nurse-led Home-Based ART initiation);
The primary objective is to identify a cost-effective package comprised of male-specific counseling, peer support, community ART distribution and/or home-based ART services for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. The specific objectives are:
Aim 1. Evaluate the effectiveness of the Stepped ART Intervention (Arm 3) vs male counseling and facility navigation (Arm 1) (primary analysis) and the effectiveness of the Stepped ART Intervention (Arm 3) vs home-based ART initiation with a nurse (Arm 2) (secondary analysis) on ART initiation within 4-months after enrollment in the trial.
Aim 2. Identify individual-, community-, and facility-level factors associated with ART initiation within each intervention arm (male counseling, home-based ART and Stepped intervention) using baseline and semi-structured in-depth interviews.
Aim 3. Determine the cost-effectiveness and scalability of the intervention arms through costing and mathematical modeling.
An individually randomized control trial will be performed with 545 HIV-positive men. Men will be individually randomized 1:1:1 to one of the three intervention arms described above. They will receive their assigned intervention over the course of three months or until the participant initiates ART. The study will be preformed at 10 health facilities supported by Partners in Hope (PIH). Data collection will include baseline and follow-up surveys at 2- and 4-months; medical charter reviews at 2- and 4-months after study enrollment; qualitative interviews with a subset of men and their female partners; and a cost analysis of costs associated with each arm. Male participants will be enrolled in the study for a total of 4 months.
The investigators anticipate learning about the most effective stragty to engage men in ART. The investigators also anticipate learning about the type and degree of followup necessary to support men's engagement in ART services. Finally, the investigators anticipate learning about the cost-effectiveness of intervention, with the goal of improving cost-effectiveness for the Ministry of Health. Results from this study could be used to define best practices and to further scale ART-focused programs for men in Malawi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Male-specific counseling and facility navigation | Experimental | Other: Male Counseling and Facility Navigation |
| Home-Based ART Initiation | Experimental | Other: Home-Based ART Initiation and Facility Navigation |
| Stepped Intervention | Experimental | Other: Stepped Intervention |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- ≥15 years of age
- Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
- Not currently engaged in ART services, defined as:
- ≥15 years of age
- Male partner enrolled in the study
Key exclusion criteria (13 listed)
- <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:
- Female partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Male Counseling and Facility NavigationAt 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 | Male-specific counseling and facility navigation |
| Home-Based ART Initiation and Facility NavigationAt 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 | Home-Based ART Initiation |
| Stepped InterventionDay 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. | Other | Stepped Intervention |
Primary outcome
Proportion of men who are retained on ART early
Time frame: 4-months.
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.
2 secondary outcomes
Proportion of men who initiate ART
Time frame: 3-months
Any adverse events self-reported by female ART client or male partner
Time frame: 4-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 41916615Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko AT. Implementation of male-specific motivational interviewing in Malawi: an assessment of intervention fidelity and barriers to scale-up. BMJ Glob Health. 2026 Mar 31;11(3):e018269. doi: 10.1136/bmjgh-2024-018269.
- Derived from this study: PubMed 40018627Hubbard 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.
- Derived from this study: PubMed 39399024Holland 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.
- Derived from this study: PubMed 37438067Dovel 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in an article after deidentification (text, tables, figures and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male Counseling and Facility Navigation, Home-Based ART Initiation and Facility Navigation and Stepped Intervention in people with Hiv, run by University of California, Los Angeles at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of men who are retained on ART early (time frame: 4-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137210, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.