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

NCT02038582 | Completed

• 1 other identifier: 44549-A
• Study Type: interventional
• Target: 2,075
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; HIV Counseling and Testing; Linkages to Care; Point of Care CD4; Point of Care Viral Load

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  Up to 12 months

Study Arms (11)

POC CD4 & Clinic Accompaniment

ACTIVE COMPARATOR

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

Other: POC CD4 Testing; Behavioral: Clinic Accompaniment

POC CD4 & Lay Counselor

ACTIVE COMPARATOR

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

Other: POC CD4 Testing; Behavioral: Lay Counselor Follow-up

POC CD4 & Clinic Referral

ACTIVE COMPARATOR

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

Other: POC CD4 Testing; Behavioral: Clinic Referral

CD4 Referral & Clinic Accompaniment

ACTIVE COMPARATOR

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

Other: CD4 Referral; Behavioral: Clinic Accompaniment

CD4 Referral & Lay Counselor

ACTIVE COMPARATOR

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

Other: CD4 Referral; Behavioral: Lay Counselor Follow-up

CD4 Referral & Clinic Referral

ACTIVE COMPARATOR

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

Other: CD4 Referral; Behavioral: Clinic Referral

Circumcision - SMS Reminder

ACTIVE COMPARATOR

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

Behavioral: SMS Reminder

Circumcision - Lay Counselor

ACTIVE COMPARATOR

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

Behavioral: Lay Counselor Follow-up

Circumcision - Promotion

ACTIVE COMPARATOR

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

Behavioral: Circumcision Promotion

POC VL

ACTIVE COMPARATOR

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

Other: POC VL

Laboratory based VL assay

ACTIVE COMPARATOR

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

Other: Laboratory based VL assay

Interventions

POC CD4 Testing OTHER

Point of Care CD4 testing

POC CD4 & Clinic Accompaniment; POC CD4 & Clinic Referral; POC CD4 & Lay Counselor

CD4 Referral OTHER

Referral to CD4 testing

CD4 Referral & Clinic Accompaniment; CD4 Referral & Clinic Referral; CD4 Referral & Lay Counselor

Lay Counselor Follow-up BEHAVIORAL

Follow-up from a lay counselor

CD4 Referral & Lay Counselor; Circumcision - Lay Counselor; POC CD4 & Lay Counselor

Clinic Accompaniment BEHAVIORAL

Accompaniment to the clinic by a counselor

CD4 Referral & Clinic Accompaniment; POC CD4 & Clinic Accompaniment

Clinic Referral BEHAVIORAL

Referral to clinic

CD4 Referral & Clinic Referral; POC CD4 & Clinic Referral

SMS Reminder BEHAVIORAL

SMS reminder for male circumcision

Circumcision - SMS Reminder

Circumcision Promotion BEHAVIORAL

Promotion of male circumcision at the time of HIV testing

Circumcision - Promotion

POC VL OTHER

POC VL testing for HIV infected persons on ART

POC VL

Laboratory based VL assay OTHER

Laboratory based viral load testing for HIV infected persons on ART

Laboratory based VL assay

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Human Sciences Research Council (HSRC)

Sweetwaters, KwaZulu-Natal, South Africa

Location

Intergrated Community Based Initivatives (ICOBI)

Kabwohe, Bushenyi, Uganda

Location

Related Publications (1)

• 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.

  PMID: 27126488 DERIVED

Study Officials

• Connie Celum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Epidemiology and Global Health

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 16, 2014
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

ZA (1); UG (1)