A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

Not Applicable

Active, not recruiting

• Conditions: HIV; Alcohol Drinking; Cost Effectiveness; Hypertension; Maternal Child Health
• Interventions: Other: Standard of Care; Other: Health Living Intervention for Heavy Alcohol Users; Other: PrEP/PEP at Antenatal Clinics; Other: PrEP/PEP at Outpatient Clinics; Other: Mobility Dynamic Treatment Intervention; Other: Hypertension Linkage; Other: Hypertension Community; Other: PrEP/PEP at Community Households

• Registration Number: NCT04810650
• Lead Sponsor: University of California, San Francisco

Brief Summary

The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.

Detailed Description

The study will conduct randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. The study will conduct two randomization trials to evaluate dynamic treatment interventions tailored to the needs of heavy alcohol users and mobile populations. The study will conduct three randomized trials to evaluate dynamic choice prevention interventions delivered in the context of antenatal clinics, the outpatient department, and in the community delivered by village health teams. The trial will conduct a randomized trial to evaluate a linkage intervention for patients with hypertension and a randomized trial to evaluate a clinic vs. community based intervention for hypertension.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-04-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREP/PEP at Community Households Control	Standard of Care	-
Healthy Living for Heavy Alcohol Users Intervention	Health Living Intervention for Heavy Alcohol Users	-
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PrEP/PEP at Antenatal Clinics	-
PREP/PEP at Antenatal Clinics Control	Standard of Care	-
Mobility Control	Standard of Care	-
Heavy Alcohol Users Control	Standard of Care	-
Hypertension Linkage Control	Standard of Care	-
PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PrEP/PEP at Outpatient Clinics	-
Mobility Dynamic Treatment Intervention	Mobility Dynamic Treatment Intervention	-
Hypertension Linkage Intervention	Hypertension Linkage	-
Hypertension Community Intervention	Hypertension Community	-
PREP/PEP at Outpatient Clinics Control	Standard of Care	-
PREP/PEP at Community Households Dynamic Prevention Intervention	PrEP/PEP at Community Households	-
Hypertension Community Control	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with hypertension control <140/90 mmHg	24 weeks	Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \<140 mmHg systolic and \<90 mmHg diastolic.
Number of participants with viral suppression defined by HIV RNA<400 cps/ml	24 weeks	Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records.
Number of participants to linked to hypertension care	30 days	Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records.
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP	48 weeks	Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report.

Trial Locations

Locations (2)

IDRC Southwest Uganda; 🇺🇬 Mbarara, Uganda

GPRT / SEARCH Office; 🇰🇪 Kisumu, Kenya