Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa - Full Text View

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of Washington:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	13000
Study Start Date:	June 2013
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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:

N/A

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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
Study First Received:	December 18, 2013
Last Updated:	February 6, 2015
Health Authority:	United States: Institutional Review Board Uganda: National Council for Science and Technology Uganda: Research Ethics Committee Uganda: Ministry of Health South Africa: Human Sciences Research Council

Keywords provided by University of Washington:


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

ClinicalTrials.gov processed this record on February 26, 2015