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

University of Washington

Status: Completed

Conditions: HIV

Treatments: Behavioral: Clinic Referral; Other: CD4 Referral; Behavioral: Clinic Accompaniment; Other: Laboratory based VL assay; Behavioral: SMS Reminder; Other: POC CD4 Testing; Behavioral: Lay Counselor Follow-up; Behavioral: Circumcision Promotion; Other: POC VL

Study type: Interventional

Funder types: Other

Identifiers

NCT02038582

44549-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,075 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,075 participants in 11 patient groups

POC CD4 & Clinic Accompaniment

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment

Treatment:

Other: POC CD4 Testing

Behavioral: Clinic Accompaniment

POC CD4 & Lay Counselor

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up

Treatment:

Behavioral: Lay Counselor Follow-up

Other: POC CD4 Testing

POC CD4 & Clinic Referral

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic

Treatment:

Other: POC CD4 Testing

Behavioral: Clinic Referral

CD4 Referral & Clinic Accompaniment

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment

Treatment:

Other: CD4 Referral

Behavioral: Clinic Accompaniment

CD4 Referral & Lay Counselor

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up

Treatment:

Behavioral: Lay Counselor Follow-up

Other: CD4 Referral

CD4 Referral & Clinic Referral

Active Comparator group

Description:

HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic

Treatment:

Other: CD4 Referral

Behavioral: Clinic Referral

Circumcision - SMS Reminder

Active Comparator group

Description:

HIV negative uncircumcised males, randomized to SMS reminder for male circumcision

Treatment:

Behavioral: SMS Reminder

Circumcision - Lay Counselor

Active Comparator group

Description:

HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision

Treatment:

Behavioral: Lay Counselor Follow-up

Circumcision - Promotion

Active Comparator group

Description:

HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing

Treatment:

Behavioral: Circumcision Promotion

POC VL

Active Comparator group

Description:

HIV positive persons on ART, randomized to POC viral load testing

Treatment:

Other: POC VL

Laboratory based VL assay

Active Comparator group

Description:

HIV positive persons on ART, randomized to laboratory based viral load testing

Treatment:

Other: Laboratory based VL assay