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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038582
• Other study ID #: 44549-A
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: May 29, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: National Council for Science and TechnologyUganda: Research Ethics CommitteeUganda: Ministry of HealthSouth Africa: Human Sciences Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2075
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• POC CD4 Testing
Point of Care CD4 testing
• CD4 Referral
Referral to CD4 testing

Behavioral:
• Lay Counselor Follow-up
Follow-up from a lay counselor
• Clinic Accompaniment
Accompaniment to the clinic by a counselor
• Clinic Referral
Referral to clinic
• SMS Reminder
SMS reminder for male circumcision
• Circumcision Promotion
Promotion of male circumcision at the time of HIV testing

Other:
• POC VL
POC VL testing for HIV infected persons on ART
• Laboratory based VL assay
Laboratory based viral load testing for HIV infected persons on ART

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council (HSRC)	Sweetwaters	KwaZulu Natal
Uganda	Intergrated Community Based Initivatives (ICOBI)	Kabwohe	Bushenyi

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Countries where clinical trial is conducted

South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 12 Months	No
Primary	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	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	Up to 9 months	No
Primary	Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral	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	Up to 12 months	No
Secondary	POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing	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.	Up to 12 months	No