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HivRISENCT06350682

Resilient HIV Implementation Science With SGM Youths Using Evidence

A study testing HealthMPowerment (HMP) in people with Hiv, run by University of Maryland, Baltimore at 3 sites in 2 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. Read more about this study

Who is it for?
Ages 15 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hiv
What is being tested?
HealthMPowerment (HMP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
3 sitesin 2 countries
Study dates
4 Mar 2026to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Male sex at birth
  • Age 15-24 years
  • Own an Android or iOS smartphone
  • Had receptive or insertive sex with another man in the past 12 months
  • Receiving care or prevention services at the CBSP-associated with the CRPS at the time of study.

Who cannot join

  • Less than 15 years old
  • Greater than 24 years old
  • Inability or cognitively impaired to provide consent
  • Does not own an Android or iOS smartphone.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

3 sites in 2 countries

Nigeria2 sites

  • Icarh/Ihvn

    Abuja, Nigeria

  • Centre for Population Health Initiative

    Lagos, Nigeria

Other trials in Nigeria

Zambia1 site

  • CIHEB Zambia Limited

    Lusaka, Zambia

Other trials in Zambia

About this study

The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.

Read the detailed description

RISE is a randomized control trial where participants are randomized (1:1) to either healthMPower (HMP) exposure for a 12 month period or delayed access to the HMP within 8 strata based on the serostatus group. HIV seropositive and HIV seronegative at risk, age group 15 to 17 or 18 to 24 years of age and country either Nigeria, Kenya, Malawi, or Zambia. Within the strata of serostatus, age, and country, participants will be randomly assigned to the next treatment allocation from a randomly permuted block sequencing using block size of four.

750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP. The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum (PHCC) for SGM youth at each of the CBSPs.

Participants who are delayed access for 12 months will be granted "Open access" for 12 months thereafter, when compared to participants who were provided access for 12 months then provided 12 months of access called "continued access" without other external support. Therefore, participants will either be provided access for 12 or 24 months depending on the randomization.

Primary outcome, clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression. Secondary outcome, PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing, linkage, and ART initiation.

Conditions
Hiv
Being tested
HealthMPowerment (HMP)
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HealthMPowerment (HMP)Behavioural

    Participants will be provided access to the status neutral platform (HMP)mobile app for 12 months exposure period or a delayed access period. The HMP is developed specific to RISE and will be adapted based off feedback from each local site via stakeholders/YABs. The HMP will encompass a range of features including a robust content management system and back end administrative dashboard, multi media resources and information center, social support features such as connections to peers and providers, interactive activities and self assessments, and flexible medication and health trackers. In addition the app will support HIV/STI test kit ordering and results portal and a gamified reward system. With real time analytics to monitor user engagement and response with the DHI we can adapt the delivery of tailored content to fit emergent HIV prevention and care challenges.

Study groups in NCT06350682
Study groupRoleWhat they receive
HealthMPowerment (HMP) Delayed AccessNo interventionDelayed access for 12 months to the HMP app, individuals will have access but it will be restricted
HealthMPowerment (HMP) Open AccessExperimentalFull access to the HMP app
Receives: Behavioral: HealthMPowerment (HMP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP initiation for HIV seronegative seropositive

    For those HIV seronegative, initiation of pre-exposure prophylaxis (PrEP) (Oral PrEP dispensed by pharmacy or Long-acting injectable defined as receiving first dose)

    Measured: 24 months

  2. Viral load suppression for HIV

    HIV seropositive viral load suppression at 12 months of taking ART (defined as HIV viral load of less than 1,000 copies/mL)

    Measured: 24 months

  3. RE-AIM

    Implementation Effectiveness on reach (characteristics of participants enrolled), Adoption (HMP physician and client interaction), Implementation (barriers and facilitators), Maintenance (HMP immediate access group at 21-24 months) and cost effectiveness of the HMP (incremental costs effectiveness ration and net monetary benefit)

    Measured: 24 months

Secondary outcomes (4)

  1. HIV testing cascade

    HIV self testing

    Measured: 12-24 months

  2. PrEP continuum

    PrEP education (restart/re-initiation)

    Measured: 12-24 months

  3. HIV care and treatment continuum

    For those HIV seropositive, antiretroviral treatment (ART) initiation and retention at 12 months

    Measured: 12-24 months

  4. Implementation effectiveness

    Study retention (participants who remained active at 24 months)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start4 Mar 2026
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350682
Sponsor's protocol ID
HP-00107323
Acronym
RISE
Status last verified
May 2026
First submitted
20 Feb 2024
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brasileiro J, Muessig KE, Lascko T, Sam-Agudu NA, Rochelle A, Mansfield ME, Ehoche A, Adebajo S, Hightow-Weidman LB, Charurat ME, Shoyemi E, Claassen CW, Trapence G, Kimani J, Aghedo OG, Ayorinde O, Sambambi K, Ndalumbira G, Gichuki R, Lavoie MC. Adapting the HealthMpowerment (HMP) mobile application for youth living with or at risk of HIV in Africa using the ADAPT-ITT model. Implement Sci Commun. 2026 Apr 13;7(1):113. doi: 10.1186/s43058-026-00913-2.

    PubMed 41968361

  • Adebajo S, Lascko T, Lavoie MC, Ehoche A, Mutumba C, Aernan NS, Nganga N, Njoroge B, Chinseu PD, Gichuki R, Ayorinde O, Aghedo OG, Sambambi K, Ndalumbira G, Ngulube MC, Chama J, Shoyemi E, Trapence G, Kimani J, Claassen CW, Sam-Agudu NA, Hightow-Weidman L, Charurat M; RISE Study. Implementing youth advisory boards with sexual minority adolescents and young men: sharing experiences, challenges and opportunities from East, South, and West Africa. Trials. 2026 Mar 11;27(1):307. doi: 10.1186/s13063-026-09596-5.

    PubMed 41808215

Questions about this trial

What is this clinical trial studying?

A study testing HealthMPowerment (HMP) in people with Hiv, run by University of Maryland, Baltimore at 3 sites in 2 countries.

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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Nigeria, Zambia. 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?

This study is still under way. Results are not available in the source record yet.

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?

PrEP initiation for HIV seronegative seropositive (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT06350682, which also lists 2 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 19 May 2026.

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