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

Not Applicable

Completed

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP	48 weeks	Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report.
Prevention Coverage Defined as Percentage of Follow-up Months 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 antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report.
Prevention Coverage Defined as Proportion of Follow-up Months 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.
Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml	48 weeks	Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.
Percentage 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 Who 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.
Percentage 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.