CHWs, mHealth, and Combination HIV Prevention (mLAKE)

• ClinicalTrials.gov Identifier: NCT02556957
• Recruitment Status: Completed
• First Posted: September 22, 2015
• Last Update Posted: August 31, 2020
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.

The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.

The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.

Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.

Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: HealthScouts; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3773 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Health Services Research
• Official Title: CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: HealthScouts Intervention; HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.	Behavioral: HealthScouts; Other: Standard of Care
Active Comparator: Standard of Care; Referral by RCCS to HIV services. Free HIV clinic available in the community.	Other: Standard of Care

Outcome Measures

Primary Outcome Measures :

1. Population Prevalence of Detectable Viremia [ Time Frame: 4 Years ]
   Proportion of the entire population who have detectable HIV viremia
2. ART Coverage (self-report) [ Time Frame: 4 Years ]
   Proportion of HIV+ persons who are on ART
3. HIV Care Coverage (self-report) [ Time Frame: 4 years ]
   Proportion of HIV+ persons who are in HIV care
4. Medical Male Circumcision Coverage (self-report) [ Time Frame: 4 years. ]
   Proportion of men who are circumcised

Secondary Outcome Measures :

1. HIV Incidence [ Time Frame: 4 years. ]
2. Sexual Behaviors (self-report) [ Time Frame: 4 years ]
   Proportion of the population which has multiple partners and/or inconsistent or no condom use
3. Population HIV Viral Load [ Time Frame: 4 years ]
   The mean viral load of HIV+ persons
4. HIV Counseling and Testing Coverage (self-report) [ Time Frame: 4 years ]
   Proportion of the entire population who have received HIV Counseling and Testing
5. HIV Prevalence [ Time Frame: 4 years ]
   The prevalence of HIV in the entire population

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Resident of Kasensero

Exclusion Criteria:

-

Contacts and Locations

Locations

Uganda

Rakai Health Sciences Program

Entebee, Uganda

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Larry W Chang; Johns Hopkins School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chang LW, Mbabali I, Hutton H, Amico KR, Kong X, Mulamba J, Anok A, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, Pollard R, van Wickle K, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray RH, Wawer MJ, Nakigozi G. Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial. PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.

Chang LW, Mbabali I, Kong X, Hutton H, Amico KR, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray R, Wawer M, Nakigozi G. Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):494. doi: 10.1186/s13063-017-2243-6.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02556957
• Other Study ID Numbers: IRB00062089
• First Posted: September 22, 2015
• Last Update Posted: August 31, 2020
• Last Verified: September 2019