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

An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: POC CD4 Testing; Behavioral: Clinic Accompaniment; Behavioral: Lay Counselor Follow-up; Behavioral: Clinic Referral; Other: CD4 Referral; Behavioral: SMS Reminder; Behavioral: Circumcision Promotion; Other: POC VL; Other: Laboratory based VL assay

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 Type: Interventional
• Enrollment (Actual): 2075
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu Natal
    • Sweetwaters, KwaZulu Natal, South Africa
      • Human Sciences Research Council (HSRC)
• Uganda
  • Bushenyi
    • Kabwohe, Bushenyi, Uganda
      • Intergrated Community Based Initivatives (ICOBI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: POC CD4 & Clinic Accompaniment; HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment	Other: POC CD4 Testing; Point of Care CD4 testing; Behavioral: Clinic Accompaniment; Accompaniment to the clinic by a counselor
Active Comparator: POC CD4 & Lay Counselor; HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up	Other: POC CD4 Testing; Point of Care CD4 testing; Behavioral: Lay Counselor Follow-up; Follow-up from a lay counselor
Active Comparator: POC CD4 & Clinic Referral; HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic	Other: POC CD4 Testing; Point of Care CD4 testing; Behavioral: Clinic Referral; Referral to clinic
Active Comparator: CD4 Referral & Clinic Accompaniment; HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment	Behavioral: Clinic Accompaniment; Accompaniment to the clinic by a counselor; Other: CD4 Referral; Referral to CD4 testing
Active Comparator: CD4 Referral & Lay Counselor; HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up	Behavioral: Lay Counselor Follow-up; Follow-up from a lay counselor; Other: CD4 Referral; Referral to CD4 testing
Active Comparator: CD4 Referral & Clinic Referral; HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic	Behavioral: Clinic Referral; Referral to clinic; Other: CD4 Referral; Referral to CD4 testing
Active Comparator: Circumcision - SMS Reminder; HIV negative uncircumcised males, randomized to SMS reminder for male circumcision	Behavioral: SMS Reminder; SMS reminder for male circumcision
Active Comparator: Circumcision - Lay Counselor; HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision	Behavioral: Lay Counselor Follow-up; Follow-up from a lay counselor
Active Comparator: Circumcision - Promotion; HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing	Behavioral: Circumcision Promotion; Promotion of male circumcision at the time of HIV testing
Active Comparator: POC VL; HIV positive persons on ART, randomized to POC viral load testing	Other: POC VL; POC VL testing for HIV infected persons on ART
Active Comparator: Laboratory based VL assay; HIV positive persons on ART, randomized to laboratory based viral load testing	Other: Laboratory based VL assay; Laboratory based viral load testing for HIV infected persons on ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Washington

Publications and helpful links

General Publications

• Barnabas RV, van Rooyen H, Tumwesigye E, Brantley J, Baeten JM, van Heerden A, Turyamureeba B, Joseph P, Krows M, Thomas KK, Schaafsma TT, Hughes JP, Celum C. Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda. Lancet HIV. 2016 May;3(5):e212-20. doi: 10.1016/S2352-3018(16)00020-5. Epub 2016 Mar 10.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: HIV; HIV Counseling and Testing; Linkages to Care; Point of Care CD4; Point of Care Viral Load
• Other Study ID Numbers: 44549-A