Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa
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ClinicalTrials.gov Identifier: NCT02038582 |
Recruitment Status
:
Completed
First Posted
: January 16, 2014
Last Update Posted
: June 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 2075 participants |
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 |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
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
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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
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Active Comparator: Circumcision - SMS Reminder
HIV negative uncircumcised males, randomized to SMS reminder for male circumcision
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Behavioral: SMS Reminder
SMS reminder for male circumcision
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Active Comparator: Circumcision - Lay Counselor
HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision
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Behavioral: Lay Counselor Follow-up
Follow-up from a lay counselor
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Active Comparator: Circumcision - Promotion
HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing
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Behavioral: Circumcision Promotion
Promotion of male circumcision at the time of HIV testing
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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
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Active Comparator: Laboratory based VL assay
HIV positive persons on ART, randomized to laboratory based viral load testing
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Other: Laboratory based VL assay
Laboratory based viral load testing for HIV infected persons on ART
|
- 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
- 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.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038582
South Africa | |
Human Sciences Research Council (HSRC) | |
Sweetwaters, KwaZulu Natal, South Africa | |
Uganda | |
Intergrated Community Based Initivatives (ICOBI) | |
Kabwohe, Bushenyi, Uganda |
Principal Investigator: | Connie Celum, MD, MPH | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | January 16, 2014 Key Record Dates |
Last Update Posted: | June 2, 2015 |
Last Verified: | May 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 |