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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

December 18, 2013
January 14, 2014
June 2013
March 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02038582 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV
  • Other: POC CD4 Testing
    Point of Care CD4 testing
  • Other: CD4 Referral
    Referral to CD4 testing
  • Behavioral: Lay Counselor Follow-up
    Follow-up from a lay counselor
  • Behavioral: Clinic Accompaniment
    Accompaniment to the clinic by a counselor
  • Behavioral: Clinic Referral
    Referral to clinic
  • Behavioral: SMS Reminder
    SMS reminder for male circumcision
  • Behavioral: Circumcision Promotion
    Promotion of male circumcision at the time of HIV testing
  • Other: POC VL
    POC VL testing for HIV infected persons on ART
  • Other: Laboratory based VL assay
    Laboratory based viral load testing for HIV infected persons on ART
  • 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
    Interventions:
    • Other: POC CD4 Testing
    • Behavioral: Clinic Accompaniment
  • Active Comparator: POC CD4 & Lay Counselor
    HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up
    Interventions:
    • Other: POC CD4 Testing
    • Behavioral: Lay Counselor Follow-up
  • Active Comparator: POC CD4 & Clinic Referral
    HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic
    Interventions:
    • Other: POC CD4 Testing
    • Behavioral: Clinic Referral
  • 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
    Interventions:
    • Other: CD4 Referral
    • Behavioral: Clinic Accompaniment
  • 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
    Interventions:
    • Other: CD4 Referral
    • Behavioral: Lay Counselor Follow-up
  • Active Comparator: CD4 Referral & Clinic Referral
    HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic
    Interventions:
    • Other: CD4 Referral
    • Behavioral: Clinic Referral
  • Active Comparator: Circumcision - SMS Reminder
    HIV negative uncircumcised males, randomized to SMS reminder for male circumcision
    Intervention: Behavioral: SMS Reminder
  • Active Comparator: Circumcision - Lay Counselor
    HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision
    Intervention: Behavioral: Lay Counselor Follow-up
  • Active Comparator: Circumcision - Promotion
    HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing
    Intervention: Behavioral: Circumcision Promotion
  • Active Comparator: POC VL
    HIV positive persons on ART, randomized to POC viral load testing
    Intervention: Other: POC VL
  • Active Comparator: Laboratory based VL assay
    HIV positive persons on ART, randomized to laboratory based viral load testing
    Intervention: Other: Laboratory based VL assay
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
13000
April 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact: Connie Celum, MD,MPH 206-520-3825 ccelum@uw.edu
Contact: Ruanne Barnabas, MBChB, DPhil (206) 520-3813 rbarnaba@uw.edu
South Africa,   Uganda
 
NCT02038582
44549-A
No
Connie Celum, University of Washington
University of Washington
Not Provided
Principal Investigator: Connie Celum, MD, MPH University of Washington
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP