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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 18, 2013
First Posted Date  ICMJE January 16, 2014
Last Update Posted Date June 2, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE HIV
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
2075
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)
13000
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038582
Other Study ID Numbers  ICMJE 44549-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Celum, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Connie Celum, MD, MPH University of Washington
PRS Account University of Washington
Verification Date May 2015

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