NCT02438930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started May 2008

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

3.8 years

First QC Date

May 6, 2015

Last Update Submit

May 7, 2015

Conditions

HIVSexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Sexual risk behavior

    Unprotected sex with serodiscordant or unknown HIV status partners

    6 months

Secondary Outcomes (1)

  • Uptake of partner testing

    6 months

Study Arms (2)

Motivational interviewing counseling

EXPERIMENTAL

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

Behavioral: Motivational interviewing intervention during HIV testing

Standard of care counseling

ACTIVE COMPARATOR

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

Behavioral: Standard-of-care counseling during HIV testing

Interventions

Motivational interviewing intervention during HIV testingBEHAVIORAL
Motivational interviewing counseling
Standard-of-care counseling during HIV testingBEHAVIORAL
Standard of care counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gombe Hospital

Gombe, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 24058127BACKGROUND

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Susan M Kiene, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

May 1, 2008

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

UG(1)