Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa

Not Applicable

Completed

• Conditions: HIV

• Registration Number: NCT02038582
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.

Detailed Description

New strategies for HIV testing and linkages to care are needed, since only a minority of African adults have been tested in many settings and a drop-off occurs at each step from HIV and CD4 testing, remaining in pre-ART (antiretroviral therapy) care, ART initiation, and adherence over the long term.

This study aims to determine the effects of Point-of-Care (POC) CD4 testing, POC viral load (VL) testing and several linkage strategies (lay-counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinical referral) on linkage to care and treatment adherence for HIV positive persons.

This study also aims to determine the uptake of voluntary circumcision among HIV uninfected males with either promotion at point of HIV testing, Short Message Service (SMS) follow-up or lay counselor follow-up visits.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2075

Inclusion Criteria

• Reside in the study community
• Must be 16 years or older
• Able and willing to provide informed consent/assent for study procedures
• HIV negative uncircumcised men must be age 16 - 49 years and have access to secure text messaging to be randomized to strategies for male circumcision.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing	Up to 12 Months	Proportion of HIV positive individuals in the POC CD4 arm who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load \<50 copies/mL within 9 months compared to those in the clinic referral arm.
Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits	Up to 9 months	Proportion of HIV-uninfected men who visit a male circumcision clinic or outreach venue for information about circumcision and proportion who report being circumcised by month 3 and 9 in the lay-counselor arm compared to the SMS follow-up arm, and male circumcision promotion at HIV testing arm
Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral	Up to 12 months	Proportion of HIV positive individuals not on ART at baseline who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load \<50 copies/mL within 9 months in the lay counselor follow-up arm compared to the accompaniment and clinic referral arms

Secondary Outcome Measures

Name	Time	Method
POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing	Up to 12 months	Proportion of HIV positive persons with viral load \<50 copies/mL at 3 months among those who receive POC viral load testing compared to those participants who receive standard laboratory-based viral load testing.

Trial Locations

Locations (2)

Human Sciences Research Council (HSRC); 🇿🇦 Sweetwaters, KwaZulu Natal, South Africa

Intergrated Community Based Initivatives (ICOBI); 🇺🇬 Kabwohe, Bushenyi, Uganda