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Completed

NCT Number: NCT02038582

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

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Sciences Research Council (HSRC), Sweetwaters, KwaZulu-Natal, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POC CD4 Testing

Other

Point of Care CD4 testing

CD4 Referral

Other

Referral to CD4 testing

Lay Counselor Follow-up

Behavioral

Follow-up from a lay counselor

Clinic Accompaniment

Behavioral

Accompaniment to the clinic by a counselor

Clinic Referral

Behavioral

Referral to clinic

SMS Reminder

Behavioral

SMS reminder for male circumcision

Circumcision Promotion

Behavioral

Promotion of male circumcision at the time of HIV testing

POC VL

Other

POC VL testing for HIV infected persons on ART

Laboratory based VL assay

Other

Laboratory based viral load testing for HIV infected persons on ART

Primary outcomes

  1. 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.

  2. 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

  3. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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