Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362791
Status:
COMPLETED
Last Update Posted:
2006-08-10
First Post:
2006-08-08
Brief Title:
Project RESPECT The Efficacy of HIVSTD Prevention Counseling
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Multicenter Randomized Controlled Trial Evaluating the Efficacy of HIVSTD Prevention Counseling and Testing in Preventing High Risk Behaviors and New Sexually Transmitted Diseases Project RESPECT
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy of counseling to prevent infection with the human immunodeficiency virus HIV and other sexually transmitted diseases STDs has not been definitively shown This multi-center randomized controlled trial Project RESPECT sought to compare the effects of 2 interactive HIVSTD counseling interventions with didactic prevention messages typical of current practice
A total of 5758 STD clinic patients were enrolled from 5 public STD clinics Baltimore Md Denver Colo Long Beach Calif Newark NJ and San Francisco Calif between July 1993 and September 1996 Eligible participants were heterosexual HIV-negative patients aged 14 years or older who came for full STD examinations Using a block design participating men and women were randomzied separately to 1 of 3 individual face-to-face interventions Arm 1 received enhanced counseling consisting of 4 interactive counseling sessions based on the Theory of Reasoned Action and Health Belief Model Arm 2 received brief counseling consisting of 2 interactive risk-reduction sessions based on CDCs client-centered counseling model Arms 3 and 4 each received 2 brief didactic messages about HIVSTD prevention messages typical of current care at that time Participants assigned to Arms 1 2 and 3 were actively followed up after enrollment with questionnaires at 3 6 9 and 12 months and STD laboratory examinations and tests at 6 and 12 months An intent-to-treat analysis was used to compare interventions Arm 4 participants were followed passively to determine potential effects of active study follow-up
The main outcome measures were self-reported condom use and new diagnoses of STDs gonorrhea chlamydia syphilis HIV defined by laboratory tests
Results At the 3- and 6-month follow-up visits self-reported 100 condom use was higher P05 in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm Through the 6-month interval 30 fewer participants had new STDs in both the enhanced counseling 72 P 002 and brief counseling 73P005 arms compared with those in the didactic messages arm 104 Through the 12-month study 20 fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm P 008 Consistently at each of the 5 study sites STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment
Subset analyses found that
Based on these results we conclude that short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs Effective counseling can be conducted even in busy public clinics
A total of 5758 STD clinic patients were enrolled from 5 public STD clinics Baltimore Md Denver Colo Long Beach Calif Newark NJ and San Francisco Calif between July 1993 and September 1996 Eligible participants were heterosexual HIV-negative patients aged 14 years or older who came for full STD examinations Using a block design participating men and women were randomzied separately to 1 of 3 individual face-to-face interventions Arm 1 received enhanced counseling consisting of 4 interactive counseling sessions based on the Theory of Reasoned Action and Health Belief Model Arm 2 received brief counseling consisting of 2 interactive risk-reduction sessions based on CDCs client-centered counseling model Arms 3 and 4 each received 2 brief didactic messages about HIVSTD prevention messages typical of current care at that time Participants assigned to Arms 1 2 and 3 were actively followed up after enrollment with questionnaires at 3 6 9 and 12 months and STD laboratory examinations and tests at 6 and 12 months An intent-to-treat analysis was used to compare interventions Arm 4 participants were followed passively to determine potential effects of active study follow-up
The main outcome measures were self-reported condom use and new diagnoses of STDs gonorrhea chlamydia syphilis HIV defined by laboratory tests
Results At the 3- and 6-month follow-up visits self-reported 100 condom use was higher P05 in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm Through the 6-month interval 30 fewer participants had new STDs in both the enhanced counseling 72 P 002 and brief counseling 73P005 arms compared with those in the didactic messages arm 104 Through the 12-month study 20 fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm P 008 Consistently at each of the 5 study sites STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment
Subset analyses found that
Based on these results we conclude that short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs Effective counseling can be conducted even in busy public clinics
Detailed Description:
See Primary Paper
Kamb ML Fishbein M Douglas JM Rhodes F Rogers J Bolan G Zenilman J Hoxworth T Malotte CK Iatesta M Kent C Lentz A Graziano S Byers RH Peterman TA Project RESPECT Study Group Efficacy of risk reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases a randomized controlled trial Project RESPECT JAMA 1998 2801161-1167
Also see
Thompson DL Douglas JM Foster M Hagensee ME DiGuiseppi C Barón AE Cameron JE Spencer TC Zenilman J Malotte CK Bolan G Kamb ML Peterman TA for the Project RESPECT Study Group HPV-16 Seroepidemiology in STD Clinics J Infect Dis in press
Bolu OO Lindsey C Kamb ML Kent C Zenilman J Douglas JM Malotte CK Rogers J Peterman TA for the Project RESPECT Study Group Is HIVSTD Prevention Counseling Effective Among Vulnerable Populations A Subset Analysis of Data Collected for a Randomized Controlled Trial Evaluating Counseling Efficacy Project RESPECT Sex Transm Dis 2004 318 469-74
Gottlieb SL Douglas JM Foster M Schmid DS Newman DR Baron AE Bolan G Iatesta M Malotte CK Zenilman J Fisbhbein M Peterman TA Kamb ML for the Project RESPECT STudy Group Incidence of herpes simplex virus type 2 infection in five sexually transmitted disease clinics and the effect of HIVSTD risk reduction counseling J Infect Dis 2004 190 1059-67
Pealer Lisa et al Are Counselor Demographics Associated with Successful HIVSTD Prevention Counseling Sexually Transmitted Diseases In press
Warner L Newman DR Austin HA Kamb ML Douglas JM Malotte CK Zenilman JM Rogers J Bolan G Fishbein M Kleinbaum DG Macaluso M Peterman TA Condom effectiveness for reducing transmission of gonorrhea and chlamydia the importance of assessing partner infection status Am J Epidemiol 2004 1593 242-51
Lyss SA Kamb ML Peterman TA Moran JS Newman DR Bolan GA Douglas JM Jr Iatesta M Malotte CK Zenilman J Ehret J Gaydos C Newhall WJ for the Project RESPECT Study Group Chlamydia trachomatis among patients infected with and treated for Neisseria gonorrhoeae in sexually transmitted disease clinics in the United States Annals Int Med 2003 1393 178-85
Gottlieb SL Douglas JM Jr Schmid DS Bolan G Iatesta M Malotte CK Zenilman J Foster M Baron AE Steiner JF Peterman TA Kamb ML for the Project RESPECT Study Group Seroprevalence and correlates of herpes simplex virus type 2 infection in five Sexually Transmitted-Disease clinics J Infect Dis 2002 186 15 November
Fishbein M Hennessy M Kamb M Bolan GA Hoxworth T Iatesta M Fhodes F Zenilman JM for the Project RESPECT Study Group Using intervention theory to model factors influencing behavior change Project RESPECT Evaluation and the Health Professions2001 424363-384
Lawrence JM Zenilman J Kamb ML Iatesta M Douglas JM Rhodes F Bolan G Fishbein M Peterman TA for the Project RESPECT Study Group Sources of recent sexually transmitted disease STD-related health care for STD clinic patients Sex Transm Dis 2001 288 1-4
Diseker RA Lin L Kamb ML Peterman TA Kent C Zenilman JM Lentz A Douglas JM Rhodes F Malotte CK Iatesta M for the Project RESPECT Study Group Fleeting Foreskins The misclassification of male circumcision status Sex Transm Dis 2001 286 330-335
Diseker RA III Peterman TA Kamb M Kent C Zenilman JM Douglas JM Rhodes F Iatesta M Circumcision and STD in the United States cross-sectional and cohort analyses Sex Transm Infect 2000 76 474-479
Peterman TA Lin LS Newman DR Kamb ML Bolan G Zenilman J Douglas JM Rogers J Malotte CK Project RESPECT Study Group Does measured behavior reflect STD risk Sex Transm Dis 2000 27 446-451
Crosby R Newman D Kamb ML Zenilman J Douglas JM Iatesta M for the Project RESPECT Study Group Misconceptions about STD protective behavior Am J Prev Med 2000 19 3167-173
Malotte CK Jarvis B Fishbein M Kamb ML Iatatesta M Hoxworth T Zenilman J Bolan G for the Project RESPECT Study Group Stage-of-change vs an integrated psychosocial theory as a basis for developing effective behavior change interventions AIDS Care 2000 12357-364
Albarracin D Ho R McNatt P S Williams W R Rhodes F Malotte C K Hoxworth T Bolan G Zenilman J Iatesta M The Project RESPECT Study Group Structure of beliefs about condom use Health Psychology 200019458-468
Hennessy M Bolan GA Hoxworth T Iatesta M Rhodes F Zenilman JM Project RESPECT Study Group Using growth curves to determine the timing of booster sessions Structural Equation Modeling 1999 64 322-342
Kamb ML Rhodes F Hoxworth T Rogers J Lentz A Kent C Peterman TA MacGowan R Project RESPECT Study Group What about money Effect of small monetary incentives on enrollment retention and motivation to change behavior in an HIVSTD prevention counseling intervention Sex Transm Infect 1998 74253-255
McGill W Miller K Bolan G Malotte K Zenilman J Iatesta M Kamb ML Douglas JM Jr for the Project RESPECT Study Group Awareness of and experience with the female condom among patients attending STD clinics Sex Transm Dis 1998 254 222-223
Kamb ML Fishbein M Douglas JM Rhodes F Rogers J Bolan G Zenilman J Hoxworth T Malotte CK Iatesta M Kent C Lentz A Graziano S Byers RH Peterman TA Project RESPECT Study Group Efficacy of risk reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases a randomized controlled trial Project RESPECT JAMA 1998 2801161-1167
Also see
Thompson DL Douglas JM Foster M Hagensee ME DiGuiseppi C Barón AE Cameron JE Spencer TC Zenilman J Malotte CK Bolan G Kamb ML Peterman TA for the Project RESPECT Study Group HPV-16 Seroepidemiology in STD Clinics J Infect Dis in press
Bolu OO Lindsey C Kamb ML Kent C Zenilman J Douglas JM Malotte CK Rogers J Peterman TA for the Project RESPECT Study Group Is HIVSTD Prevention Counseling Effective Among Vulnerable Populations A Subset Analysis of Data Collected for a Randomized Controlled Trial Evaluating Counseling Efficacy Project RESPECT Sex Transm Dis 2004 318 469-74
Gottlieb SL Douglas JM Foster M Schmid DS Newman DR Baron AE Bolan G Iatesta M Malotte CK Zenilman J Fisbhbein M Peterman TA Kamb ML for the Project RESPECT STudy Group Incidence of herpes simplex virus type 2 infection in five sexually transmitted disease clinics and the effect of HIVSTD risk reduction counseling J Infect Dis 2004 190 1059-67
Pealer Lisa et al Are Counselor Demographics Associated with Successful HIVSTD Prevention Counseling Sexually Transmitted Diseases In press
Warner L Newman DR Austin HA Kamb ML Douglas JM Malotte CK Zenilman JM Rogers J Bolan G Fishbein M Kleinbaum DG Macaluso M Peterman TA Condom effectiveness for reducing transmission of gonorrhea and chlamydia the importance of assessing partner infection status Am J Epidemiol 2004 1593 242-51
Lyss SA Kamb ML Peterman TA Moran JS Newman DR Bolan GA Douglas JM Jr Iatesta M Malotte CK Zenilman J Ehret J Gaydos C Newhall WJ for the Project RESPECT Study Group Chlamydia trachomatis among patients infected with and treated for Neisseria gonorrhoeae in sexually transmitted disease clinics in the United States Annals Int Med 2003 1393 178-85
Gottlieb SL Douglas JM Jr Schmid DS Bolan G Iatesta M Malotte CK Zenilman J Foster M Baron AE Steiner JF Peterman TA Kamb ML for the Project RESPECT Study Group Seroprevalence and correlates of herpes simplex virus type 2 infection in five Sexually Transmitted-Disease clinics J Infect Dis 2002 186 15 November
Fishbein M Hennessy M Kamb M Bolan GA Hoxworth T Iatesta M Fhodes F Zenilman JM for the Project RESPECT Study Group Using intervention theory to model factors influencing behavior change Project RESPECT Evaluation and the Health Professions2001 424363-384
Lawrence JM Zenilman J Kamb ML Iatesta M Douglas JM Rhodes F Bolan G Fishbein M Peterman TA for the Project RESPECT Study Group Sources of recent sexually transmitted disease STD-related health care for STD clinic patients Sex Transm Dis 2001 288 1-4
Diseker RA Lin L Kamb ML Peterman TA Kent C Zenilman JM Lentz A Douglas JM Rhodes F Malotte CK Iatesta M for the Project RESPECT Study Group Fleeting Foreskins The misclassification of male circumcision status Sex Transm Dis 2001 286 330-335
Diseker RA III Peterman TA Kamb M Kent C Zenilman JM Douglas JM Rhodes F Iatesta M Circumcision and STD in the United States cross-sectional and cohort analyses Sex Transm Infect 2000 76 474-479
Peterman TA Lin LS Newman DR Kamb ML Bolan G Zenilman J Douglas JM Rogers J Malotte CK Project RESPECT Study Group Does measured behavior reflect STD risk Sex Transm Dis 2000 27 446-451
Crosby R Newman D Kamb ML Zenilman J Douglas JM Iatesta M for the Project RESPECT Study Group Misconceptions about STD protective behavior Am J Prev Med 2000 19 3167-173
Malotte CK Jarvis B Fishbein M Kamb ML Iatatesta M Hoxworth T Zenilman J Bolan G for the Project RESPECT Study Group Stage-of-change vs an integrated psychosocial theory as a basis for developing effective behavior change interventions AIDS Care 2000 12357-364
Albarracin D Ho R McNatt P S Williams W R Rhodes F Malotte C K Hoxworth T Bolan G Zenilman J Iatesta M The Project RESPECT Study Group Structure of beliefs about condom use Health Psychology 200019458-468
Hennessy M Bolan GA Hoxworth T Iatesta M Rhodes F Zenilman JM Project RESPECT Study Group Using growth curves to determine the timing of booster sessions Structural Equation Modeling 1999 64 322-342
Kamb ML Rhodes F Hoxworth T Rogers J Lentz A Kent C Peterman TA MacGowan R Project RESPECT Study Group What about money Effect of small monetary incentives on enrollment retention and motivation to change behavior in an HIVSTD prevention counseling intervention Sex Transm Infect 1998 74253-255
McGill W Miller K Bolan G Malotte K Zenilman J Iatesta M Kamb ML Douglas JM Jr for the Project RESPECT Study Group Awareness of and experience with the female condom among patients attending STD clinics Sex Transm Dis 1998 254 222-223
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R30CCR207113-03 | None | None | None |
| R30CCR307116-01 | None | None | None |
| R30CCR807114-04 | None | None | None |
| R33CCR907111-03 | None | None | None |
| R30CCR907117-03 | None | None | None |