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

N/ACompletedNCT02038582

University of Washington2,075 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

2,075

Conditions

HIV

Interventions

POC CD4 TestingOTHER

Point of Care CD4 testing

CD4 ReferralOTHER

Referral to CD4 testing

Lay Counselor Follow-upBEHAVIORAL

Follow-up from a lay counselor

Clinic Accompaniment

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Human Sciences Research Council (HSRC)

Sweetwaters, KwaZulu-Natal, South Africa

Intergrated Community Based Initivatives (ICOBI)

Kabwohe, Bushenyi, Uganda

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 12 Months

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

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

Time frame: Up to 9 months

Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral

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

Time frame: Up to 12 months

Secondary Outcomes

POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing

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.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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