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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Washington


Information provided by (Responsible Party)
Connie Celum, University of Washington

ClinicalTrials.gov Identifier
NCT02038582

First received: December 18, 2013
Last updated: May 29, 2015
Last Verified: May 2015
History of Changes
Purpose

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
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

Further study details as provided by Connie Celum, 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 ]
    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.

Enrollment: 2075
Study Start Date: June 2013
Study Completion Date: February 2015
Primary Completion Date: February 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

Eligibility

Ages Eligible for Study: 16 Years and older  
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

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

More Information


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: May 29, 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

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.