# Presentation: 207440

## Perspectives on HIV Prevention Counseling from the RESPECT-2 Study

- Kevin Malotte, Suzanne Padilla, and Carol Metcalf, on behalf of the RESPECT-2 Study Group

## Session Outline

- RESPECT-2 Study Overview
- Counselor Observations on HIV Rapid Test Counseling
- Client Preferences Regarding HIV Testing and Counseling
- Success at Achieving Client-Generated Risk-Reduction Plans

***Session Outline***

## Project RESPECTOverview

- Five public STD clinics
- Long Beach, San Francisco, Denver, Baltimore, and Newark
- July 1993-September 1996
- Participants
- 5758 heterosexual, HIV-negative patients aged 14 years or older who came into the clinic for STD examinations

**Project RESPECT*****Overview***

## Project RESPECT Study Sites 

**San**** Francisco**

**Long Beach**

**Denver**

**Newark**

**Baltimore**

## Project RESPECTInterventions

- Arm 1 - Enhanced counseling/4-theory-based sessions
- Arm 2 - Brief counseling/2 interactive risk-reduction sessions
- Arm 3/Arm 4 - Didactic messages/2 brief sessions typical of current care at the time of the study
*   **(Incentives were provided for attendance at intervention sessions)*

**Project RESPECT*****Interventions***

## Project RESPECT Enrollment

## Project RESPECT Outcome Measures

- Self-reported condom use/sexual risks
- New diagnosis of STDs by laboratory tests
- gonorrhea
- chlamydia
- syphilis
- HIV

**Project RESPECT**** *****Outcome Measures***

## Project RESPECTResults

- Greatest impact among adolescents and individuals diagnosed with an STD at their initial visit

**Project RESPECT*****Results***

## Project RESPECTResults

- Through the 6-month interval, 30% fewer participants had new STDs in both the enhanced counseling and brief counseling arms (1-2)

**Project RESPECT*****Results***

## Project RESPECTResults

- Findings were consistent across all study sites

**Project RESPECT*****Results***

## RESPECT-2Background

- In non-research settings, however, many clients do not return for HIV test results and do not receive the second counseling session
- The counseling intervention was effective at preventing STDs in the first 6 months, but effectiveness lessened over time

***RESPECT-2******Background***

## RESPECT-2Background

- Rapid HIV testing technologies allow people to be tested and receive their results during a single clinic visit
- Rapid HIV tests are now available* and likely to become widely used in the future
- 	* the only licensed test has had limited availability and other tests awaiting FDA licensure

## Randomized Clinical Trial
Participants randomized to receive one of two interventions at enrollment
One half of each group randomized to receive a second intervention six months later
Participants followed for 12 months with follow-up visits at 3-month intervals (4 total)

- Participants randomized to receive one of two interventions at enrollment
- One half of each group randomized to receive a second intervention six months later
- Participants followed for 12 months with follow-up visits at 3-month intervals (4 total)

***RESPECT-2******Study Design***

## Research Setting
Three Public STD Clinics
Long Beach, Denver, and Newark
Enrollment February 1999 to December 2001
Follow-up ongoing
Investigators still blinded to participant intervention assignment

- Three Public STD Clinics
- Long Beach, Denver, and Newark
- Enrollment February 1999 to December 2001
- Follow-up ongoing
- Investigators still blinded to participant intervention assignment

***RESPECT-2******Setting & Stage***

## RESPECT-2 Study Sites 

**Long Beach**

**Denver**

**Newark**

## HIV-negative patients who came into clinic for STD examinations and provided informed consent
15-39 years of age (Denver/Long Beach);
18-39 years of age (Newark)
Participants must live in the local area, speak English, and have had sex in the past 3 months

- 15-39 years of age (Denver/Long Beach);
- 18-39 years of age (Newark)
- Participants must live in the local area, speak English, and have had sex in the past 3 months

***RESPECT-2******Participants***

## Participants Randomly Assigned
Arm 1:  Standard Testing
Standard HIV test and two risk-reduction counseling sessions 5 to 10 days apart
Arm 2:  Rapid Testing
Rapid HIV test (SUDS) and two risk-reduction counseling sessions completed in a single visit
Half of the participants are randomly assigned to receive a booster counseling session during the 6-month follow-up visit (Arms 3 and 4)

- Arm 1:  Standard Testing
- Standard HIV test and two risk-reduction counseling sessions 5 to 10 days apart
- Arm 2:  Rapid Testing
- Rapid HIV test (SUDS) and two risk-reduction counseling sessions completed in a single visit
- Half of the participants are randomly assigned to receive a booster counseling session during the 6-month follow-up visit (Arms 3 and 4)

***RESPECT-2******Interventions ***

## RESPECT-2 Enrollment

## Behavioral 
Audio Computer-Assisted Self Interview (Audio-CASI) behavioral questionnaire at baseline and each follow-up visit
STD 
Tests for gonorrhea, chlamydia, and trichomonas at enrollment and each follow-up visit
Tests for HIV and syphilis at baseline and 12-month visit

- Audio Computer-Assisted Self Interview (Audio-CASI) behavioral questionnaire at baseline and each follow-up visit
- STD
- Tests for gonorrhea, chlamydia, and trichomonas at enrollment and each follow-up visit
- Tests for HIV and syphilis at baseline and 12-month visit

***RESPECT-2******Outcomes***

## Sex
54%  Male
46%	Female
Race/ethnicity
47%  African American 
24%  White 
19%  Latino
10%  Other
Mean age 26 years (age restricted to 15-39)
Nearly 6% men who have sex with men

- 54%  Male
- 46%	Female
- Race/ethnicity
- 47%  African American
- 24%  White
- 19%  Latino
- 10%  Other
- Mean age 26 years (age restricted to 15-39)
- Nearly 6% men who have sex with men

***RESPECT-2******Participant Demographics***

## RESPECT-2Rapid Tests

- Approximately 1660 participants received SUDS
- Results:

| Site  | Preliminary SUDS + | Confirmed SUDS + by WB | Preliminary EIA+ | Confirmed EIA + by WB |
| --- | --- | --- | --- | --- |
| LB | 4 | 1 | 5 | 2 |
| Denver | 4 | 1 | 2 | 1 |
| Newark | 14 | 13 | 20 | 18 |
| Total | 22 | 15 | 27 | 21 |

## RESPECT-2Rapid Tests (continued)

-  Total HIV discrepant results:
- *In Long Beach, one SUDS positive/indeterminate WB at baseline; WB negative at 3 and 6 month follow-up

|  | SUDS-
Positive | EIA-
Positive |
| --- | --- | --- |
| WB Negative | 7* | 6 |

## RESPECT-2 - Follow-Up (for those reaching end of follow-up window and target date of 2/28/2001)

| % returned
(number   eligible) | 3 Month
Follow-up | 6 Month
Follow-up
 | 9 Month
Follow-up | 12 Month
Follow-up |
| --- | --- | --- | --- | --- |
| Long Beach | 76%  (931) | 72%  (854) | 71% (710) | 73% (555)
 |
| Denver | 77% (1238) | 75% (1131)
 | 75% (928) | 76% (651)
 |
| Newark | 68%  (1051) | 65%  (912) | 63% (731) | 58% (506)
 |
| Total
(All Sites) |  74% (3220) |  71% (2897) |  70% (2369) | 70% (1712)
 |

***RESPECT-2 - ******Follow-Up ******(for those reaching end of follow-up window ******and target date of 2/28/2001)***