# Presentation: 319628

## Randomized Controlled Trial of HIV Counseling with Rapid and Standard HIV Tests (RESPECT-2)Preliminary results

- Carol Metcalf1, Helene Cross2, Beth Dillon1, John Douglas3, C Kevin Malotte4, Paul Young5, Catherine Lindsey1, Tom Peterman1, for the RESPECT-2 Study Group
- 1CDC, 2NJ Dept. Health and Senior Services, 3Denver Public Health, 4CA State University Long Beach, 5NOVA Research Company

## RESPECT-2 Study Group

- Centers for Disease Control and Prevention: Carol Metcalf, Bob Byers, Beth Dillon, Heather Frederick, Michael Iatesta, Mary Kamb, Catherine Lindsey, Vel McKleroy, Tom Peterman, Laura Selman, Beena Varghese
- Long Beach Site: C. Kevin Malotte, David Souleles, Suzanne Padilla, Nettie DeAugustine, Judy Hollingshead
- Denver Site: John Douglas, Lesley Brooks, Ken Miller, Cornelis “Kees” Rietmeijer
- Newark Site: Sindy Paul, Helene Cross, LaVerne Parish, Lena Raveneau,
- NOVA Research Company: Paul Young, Bob Francis, Chris Gordon, Carmita Signes
- Center for AIDS Intervention Research: Seth Kalichman

## Background

- Project RESPECT: HIV testing with 2 brief (~20 minute) prevention counseling sessions more effective at preventing STDs than HIV testing with information alone.
- Influenced policy and practice of prevention counseling in US.
- BUT, low return rates for HIV test result and 2nd counseling session.

**Background**

## Background – Rapid HIV tests

- Enable preliminary HIV test result to be available within 30 minutes
- Negative results do not require confirmation
- Much higher proportion of clients receive their HIV result than with standard HIV tests
- Efficacy of completing prevention counseling in 1 visit compared to 2 visits unknown.

## Objective

- 	To compare  rapid HIV testing and all counseling in 1 visit with standard HIV testing and 2 counseling sessions a week apart for efficacy at preventing STDs in STD clinic patients.

## Randomized Controlled Trial in 3 STD clinics
Randomized:
- Rapid or standard HIV test at enrollment
- “Booster” (relapse prevention) counseling or no booster at 6 months
Follow-up at 3, 6, 9, and 12 months
Intention-to-treat analysis

- Randomized:
- - Rapid or standard HIV test at enrollment
- - “Booster” (relapse prevention) counseling or no booster at 6 months
- Follow-up at 3, 6, 9, and 12 months
- Intention-to-treat analysis

**Methods**

**Notes:**
I will not address the booster counseling in this paper but we have a poster if you’re interested.

## HIV-negative clients attending STD clinic for an STD examination
Age: 15 - 39 yrs (18 - 39 yrs Newark)
Required to consent, speak English, be available for 1 year follow-up, and have had sex in the past 3 months
Enrollment: February 1999 - December 2000

- Age: 15 - 39 yrs (18 - 39 yrs Newark)
- Required to consent, speak English, be available for 1 year follow-up, and have had sex in the past 3 months
- Enrollment: February 1999 - December 2000

**Eligibility**

## Based on Project RESPECT / CDC model
2 sessions of ~20 minutes each at baseline
HIV result given at start of 2nd session
Approach and content similar in both groups
Timing of the 2nd session:Rapid test - Same visit (after STD exam)Standard test - 1 week later
Reminder letter and calls to maximize returnfor 2nd session (standard test group)

- 2 sessions of ~20 minutes each at baseline
- HIV result given at start of 2nd session
- Approach and content similar in both groups
- Timing of the 2nd session:Rapid test - Same visit (after STD exam)Standard test - 1 week later
- Reminder letter and calls to maximize returnfor 2nd session (standard test group)

**Counseling Interventions**

## STD
Baseline and every 3 months: gonorrhea and Chlamydia (NAATs of urine), and Trichomonas (culture vaginal swab F, urine sediment M ) 
Baseline and 12-months: HIV and syphilis
Behavioral 
Audio Computer-Assisted Self Interview (ACASI) at baseline and every 3 months

- Baseline and every 3 months: gonorrhea and *Chlamydia* (NAATs of urine), and *Trichomonas* (culture vaginal swab F, urine sediment M )
- Baseline and 12-months: HIV and syphilis
**Behavioral**** **
- Audio Computer-Assisted Self Interview (ACASI) at baseline and every 3 months

**Outcome Measurement**

## Enrollment and Randomization

- Eligible 7554 (80%)

- Enrolled 3338 (44%)

- Participants 3293

- Standard Test
- 1648 (50%)

- Rapid Test
- 1645 (50%)

- No Booster
- 1652 (50%)

- Booster
- 1641 (50%)

- Excluded 45 (1%)
- (35 HIV+)

**Enrollment and Randomization**

## Sex: 46 % female
Race / ethnicity: 51 %  African-American                           22 %  White                           18 %  Hispanic                             9 %  Other
Median / mean age: Females 23 / 25 yrs;                                 Males 25 / 26 yrs 
Site: Denver 38%, Long Beach 29%,          Newark 33%

- Race / ethnicity: 51 %  African-American                           22 %  White                           18 %  Hispanic                             9 %  Other
- Median / mean age: Females 23 / 25 yrs;                                 Males 25 / 26 yrs
- Site: Denver 38%, Long Beach 29%,          Newark 33%

**Participant Demographics****(n = 3293)**

## Baseline Risk Characteristicsby HIV Test Type

| 
Characteristic | Standard(n = 1648) | Rapid(n = 1645) |
| --- | --- | --- |
| >1 partner last 3 mo | 54 % | 55 % |
| New partner last 3 mo | 66 % | 69 %* |
| MSM last 3 mo (of M) | 9 % | 10 % |
| STD at baseline | 24 %* | 26 %* |
| 
*Updated figures |  |  |

**Notes:**
Overall 54% reported having >1 partner in the 3 months before baseline.
68% had a new partner in this 3 month period.
10% of the male participants had sex with a male partner in this 3 month period.
25% of participants had a laboratory-confirmed STD at enrollment.
(Note: Need to have breakdown on STD type by sex available in case of questions.)
There were some small differences in baseline risk characteristics between the standard test and rapid test groups..

## Completion of Baseline Counseling and follow-up by HIV Test Type

**Completed counseling (%)**
**Standard   72**
**Rapid        99**
**Follow-up (% at 3, 6, 9, and 12 months)**
**Standard   71, 71, 73, 73**
**Rapid        72, 72, 71, 72**

**Notes:**
99% of the rapid test group completed their counseling compared to 72% of the standard test group.

## Cumulative Incidence of One or More STDs During Follow-up by HIV Test Type

- Standard

- Rapid

**Notes:**
Looking at the cumulative incidence of STDs during follow-up, the rates were higher in the rapid test group (shown in blue) than the standard test group (shown in yellow) at all visits. (Read numbers from slide.)
These figures represent laboratory-confirmed STDs following a negative result or treatment.
Only the first STD in each participant was counted so that figures represent the proportion of participants who had one or more STDs during follow-up. 

## Cumulative Incidence of One or More STDs During Follow-upRapid Test Group vs. Standard Test Group 

| Up to... | Risk Ratio (95% CI) | P-value |
| --- | --- | --- |
| 3 mo visit | 1.17  (0.90-1.52) | 0.25 |
| 6 mo visit | 1.23  (1.01-1.49) | 0.04 |
| 9 mo visit | 1.19  (1.01-1.40) | 0.04 |
| 12 mo visit | 1.12  (0.97-1.30) | 0.13 |

**Notes:**
This is the same information as in the previous slide shown as risk ratios.
The risk ratios represent the cumulative STD incidence in the rapid test group relative to the standard test group.
The risk ratios were all greater than 1, indicating that those in the rapid test group had a higher incidence of STDs than the standard test group, as shown on the previous slide.
By the 6-month visit, the cumulative incidence of STDs was 23% greater in the rapid test group than the standard test group. This difference was statistically significant at the 5% level.
However, by the 12-month, the cumulative incidence of STDs was only 12% greater in the rapid test group, and this difference was no longer statistically significant.
A more sophisticated analysis of STD outcomes was done using generalized estimating equations (GEE).  This enabled us to include all STDs as outcomes in those with more than one STD during follow-up. The risk ratio estimates were essentially the same as the ones shown here.

## Relative Risk of STDs During Follow-up: Rapid Test Group Compared to Standard Test Group by Site

| 
Up to... | Denver
Risk Ratio (95% CI) | Long Beach
Risk Ratio(95% CI) | Newark
Risk Ratio(95% CI) |
| --- | --- | --- | --- |
| 3 mo visit | 1.28  (0.84-1.97) | 1.00  (0.57-1.76) | 1.16  (0.77-1.75) |
| 6 mo visit | 1.25  (0.92-1.69) | 0.93  (0.60-1.43) | 1.39*  (1.03-1.88) |
| 9 mo visit | 1.25  (0.97-1.61) | 0.95  (0.65-1.37) | 1.28  (0.98-1.67) |
| 12 mo visit | 1.13  (0.97-1.42) | 0.96  (0.69-1.33) | 1.21  (0.96-1.53) |

**Notes:**
Looking at the results by clinic site, showed that at 2 of the 3 sites (Denver and Newark), those in the rapid test group had a greater risk of acquiring an STD than those in the standard test group.
At the Denver site, the risk ratio for acquiring an STD in the rapid test group relative to the standard test group ranged from 1.13 to 1.28.
At the Newark site, the risk ratio ranged from 1.16 to 1.39.
The only excess risk in the rapid test group that was statistically significant at the 5% level was for STDs acquired by the 6 month visit at the Newark site (relative risk 1.39).
However, at the Long Beach site, those in the rapid test group did not have an excess STD incidence relative to the standard test group at any stage of follow-up. The relative risks ranged from 0.93 to 1.00, and the rapid test group had slightly fewer STDs overall than the standard test group.

## Results preliminary
Substantially more patients received their HIV test result using a rapid HIV test than a standard HIV test. 
Overall standard 2-visit counseling was associated with fewer new STDs.
Differences in STD rates between groups decreased over time.

- Substantially more patients received their HIV test result using a rapid HIV test than a standard HIV test.
- Overall standard 2-visit counseling was associated with fewer new STDs.
- Differences in STD rates between groups decreased over time.

**Conclusion**

**Notes:**
These results are preliminary.
Substantially more participants receive their HIV result and complete prevention counseling when tested with a rapid HIV test, even when extra efforts are made to persuade participants tested with a standard test to return for their HIV result and second counseling session.
Overall, standard HIV testing with counseling in 2 visits was associated with fewer new STDs than in those with rapid HIV testing and counseling in 1 visit.
However, by the end of follow-up, the difference between groups in the cumulative incidence of STDs was small and not statistically significant.

## Please visit the RESPECT-2 website:www.cdc.gov/hiv/projects/respect-2