Client-Centered Counseling During Routine/Opt-Out HIV-Testing in Uganda

NCT ID: NCT02438930

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-03-31

Brief Summary

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This study pilot tests and intervention to help individuals reduce their risk for acquiring or transmitting HIV. The intervention is implemented when people are tested for HIV in an outpatient clinic in rural Uganda. Approximately half of participants will receive the intervention and the other half will receive the usual counseling provided during HIV counseling and testing.

Detailed Description

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Conditions

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HIV Sexual Behavior

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Motivational interviewing counseling

The brief intervention is adapted from the OPTIONS project, which is a brief client-centered risk reduction intervention for HIV-positive patients in clinical care. The OPTIONS intervention content is based upon the IMB model of health behavior change, and uses motivational interviewing techniques to create client-centered discussions in which HIV counselors and patients collaborate to identify patients' HIV transmission risk behaviors and to mutually identify strategies and goals for reducing the patient's risky behavior.

The brief intervention will be facilitated by health care providers (nurses, lab technicians) specifically trained in the intervention protocol and will consist of 2 brief counseling sessions occurring during the same-day rapid HIV-testing procedure

Group Type EXPERIMENTAL

Motivational interviewing intervention during HIV testing

Intervention Type BEHAVIORAL

Standard of care counseling

Participants in this study condition will receive standard-of-care counseling that is usually implemented during HIV testing.

Group Type ACTIVE_COMPARATOR

Standard-of-care counseling during HIV testing

Intervention Type BEHAVIORAL

Interventions

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Motivational interviewing intervention during HIV testing

Intervention Type BEHAVIORAL

Standard-of-care counseling during HIV testing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. at least 18 years of age,
2. have come to the outpatient clinic for a medical concern (e.g., cough, malaria, but not those seeking voluntary HIV-counseling and testing,
3. sexually active within the prior 3-months,
4. not currently pregnant,
5. no confirmed HIV-positive test result prior to the present HIV-test, and
6. live not more than 30km from Gombe Hospital in Uganda (to facilitate follow-up)

Exclusion Criteria

* less than 18 years of age,
* having come to the clinic seeking voluntary HIV-counseling and testing,
* not sexually active in prior 3 months,
* currently pregnant,
* confirmed prior HIV positive test,
* live more than 30km from the hospital
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role collaborator

Susan M. Kiene

OTHER

Sponsor Role lead

Responsible Party

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Susan M. Kiene

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Susan M Kiene, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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Gombe Hospital

Gombe, , Uganda

Site Status

Countries

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Uganda

References

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Kiene SM, Sileo K, Wanyenze RK, Lule H, Bateganya MH, Jasperse J, Nantaba H, Jayaratne K. Barriers to and acceptability of provider-initiated HIV testing and counselling and adopting HIV-prevention behaviours in rural Uganda: a qualitative study. J Health Psychol. 2015 Feb;20(2):173-87. doi: 10.1177/1359105313500685. Epub 2013 Sep 20.

Reference Type BACKGROUND
PMID: 24058127 (View on PubMed)

Other Identifiers

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K01MH083536

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SK_UG_K01

Identifier Type: -

Identifier Source: org_study_id

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