CHWs, mHealth, and Combination HIV Prevention

NCT ID: NCT02556957

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

HealthScouts Intervention

HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.

Group Type: EXPERIMENTAL

HealthScouts

Intervention Type: BEHAVIORAL

Standard of Care

Intervention Type: OTHER

Standard of Care

Referral by RCCS to HIV services. Free HIV clinic available in the community.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Interventions

HealthScouts

Intervention Type: BEHAVIORAL

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Resident of Kasensero

Exclusion Criteria

-

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry W Chang

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Rakai Health Sciences Program

Entebee, , Uganda

Countries

Uganda

References

Chang LW, Pollard R, Mbabali I, Anok A, Hutton H, Amico KR, Kong X, Mulamba J, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, van Wickle K, Kennedy CE, Nalugoda F, Beres LK, Bollinger RC, Quinn TC, Serwadda D, Gray RH, Wawer MJ, Reynolds SJ, Nakigozi G. Mixed Methods, Implementation Science Evaluation of a Community Health Worker Strategy for HIV Service Engagement in Uganda. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):28-36. doi: 10.1097/QAI.0000000000003220.

Reference Type: DERIVED

PMID: 37195924 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33406130 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29061194 (View on PubMed)

Other Identifiers

IRB00062089

Identifier Type: -

Identifier Source: org_study_id