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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT02038582
First received: December 18, 2013
Last updated: January 14, 2014
Last verified: December 2013
  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:


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

Contacts
Contact: Connie Celum, MD,MPH 206-520-3825 ccelum@uw.edu
Contact: Ruanne Barnabas, MBChB, DPhil (206) 520-3813 rbarnaba@uw.edu

Locations
South Africa
Human Sciences Research Council (HSRC) Recruiting
Sweetwaters, KwaZulu Natal, South Africa
Contact: Heidi Van Rooyen, BA, PhD    +27 33 324 1102    HvanRooyen@hsrc.ac.za   
Uganda
Intergrated Community Based Initivatives (ICOBI) Recruiting
Kabwohe, Bushenyi, Uganda
Contact: Elioda Tumwesigye, MBChB, MS    +256 772 489 632    elioda@kcrc.or.ug   
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: January 14, 2014
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

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014