CHWs, mHealth, and Combination HIV Prevention

NCT02556957 | Completed DMC

• 1 other identifier: IRB00062089
• Study Type: interventional
• Target: 3,773
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Population Prevalence of Detectable Viremia

  Proportion of the entire population who have detectable HIV viremia

  4 Years

• ART Coverage (self-report)

  Proportion of HIV+ persons who are on ART

  4 Years

• HIV Care Coverage (self-report)

  Proportion of HIV+ persons who are in HIV care

  4 years

• Medical Male Circumcision Coverage (self-report)

  Proportion of men who are circumcised

  4 years.

Secondary Outcomes (5)

• HIV Incidence

  4 years.

• Sexual Behaviors (self-report)

  4 years

• Population HIV Viral Load

  4 years

• HIV Counseling and Testing Coverage (self-report)

  4 years

• HIV Prevalence

  4 years

Study Arms (2)

HealthScouts Intervention

EXPERIMENTAL

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

Behavioral: HealthScouts; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

HealthScouts BEHAVIORAL

HealthScouts Intervention

Standard of Care OTHER

HealthScouts Intervention; Standard of Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of Kasensero

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Rakai Health Sciences Program

Entebee, Uganda

Location

Related Publications (3)

• 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.

  PMID: 37195924 DERIVED

• 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.

  PMID: 33406130 DERIVED

• 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.

  PMID: 29061194 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Larry W Chang

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 31, 2020

Record last verified: 2019-09

Locations

UG (1)