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

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ClinicalTrials.gov Identifier: NCT02038582

Recruitment Status : Completed

First Posted : January 16, 2014

Last Update Posted : June 2, 2015

Sponsor:

Information provided by (Responsible Party):

Connie Celum, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Other: POC CD4 Testing Other: CD4 Referral Behavioral: Lay Counselor Follow-up Behavioral: Clinic Accompaniment Behavioral: Clinic Referral Behavioral: SMS Reminder Behavioral: Circumcision Promotion Other: POC VL Other: Laboratory based VL assay	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2075 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	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
Study Start Date :	June 2013
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

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	Other: CD4 Referral Referral to CD4 testing Behavioral: Clinic Accompaniment Accompaniment to the clinic by a counselor
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	Other: CD4 Referral Referral to CD4 testing Behavioral: Lay Counselor Follow-up Follow-up from a lay counselor
Active Comparator: CD4 Referral & Clinic Referral HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic	Other: CD4 Referral Referral to CD4 testing Behavioral: Clinic Referral Referral to clinic
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

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 :

POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038582

Locations


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

Sponsors and Collaborators

University of Washington

Investigators


Principal Investigator:	Connie Celum, MD, MPH	University of Washington

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Connie Celum, Professor of Medicine, Epidemiology and Global Health, University of Washington
ClinicalTrials.gov Identifier:	NCT02038582 History of Changes
Other Study ID Numbers:	44549-A
First Posted:	January 16, 2014 Key Record Dates
Last Update Posted:	June 2, 2015
Last Verified:	May 2015

Keywords provided by Connie Celum, University of Washington:


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

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