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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438930
• Other study ID #: SK_UG_K01
• Secondary ID: K01MH083536
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: May 7, 2015
• Start date: May 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2015
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexual Behavior

Intervention

Behavioral:
• Motivational interviewing intervention during HIV testing

• Standard-of-care counseling during HIV testing

Locations

Country	Name	City	State
Uganda	Gombe Hospital	Gombe

Sponsors (4)

Lead Sponsor	Collaborator
Susan M. Kiene	Makerere University, National Institute of Mental Health (NIMH), Rhode Island Hospital

Country where clinical trial is conducted

Uganda, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual risk behavior	Unprotected sex with serodiscordant or unknown HIV status partners	6 months	No
Secondary	Uptake of partner testing	Partner uptake of HIV testing	6 months	No