HIVNCT00362791
Project RESPECT: The Efficacy of HIV/STD Prevention Counseling
A study testing "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model, "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior and "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies in people with HIV and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention.
Trial 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 HIV/STD counseling interventions… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases
- What is being tested?
- "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model, "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior and "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients who came to the STD clinic and who were eligible in routine clinic practice to undergo confidential HIV testing
Who cannot join
- residence outside the clinics' catchment areas
- had made firm plans (e.g., can give a new address) to move outside the clinic catchment area during the next 12 months
- unable to provide informed consent to be tested for HIV and take part in the follow up aspect of the study (e.g., incarcerated, mental status changes from drugs, alcohol, medication)
- reported that he or she had tested positive for HIV in the past
- did not speak and comprehend English well enough to participate in the interventions
- came to the clinic for something other than a full routine STD clinic examinations
Show all 9Show fewer
- was a man who reported sex with a man in the past 12 months
- had been approached for study participation on a previous clinic visit, and hd already enrolled or refused participation
- age < 14 years.
About this study
Official title: Multicenter Randomized Controlled Trial Evaluating the Efficacy of HIV/STD Prevention Counseling and Testing in Preventing High Risk Behaviors and New Sexually Transmitted Diseases (Project RESPECT)
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 HIV/STD 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 CDC's client-centered counseling model. Arms 3 and 4 each received 2 brief didactic messages about HIV/STD 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.
Read more
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 (P<.05) 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 (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms compared with those in the didactic messages arm (10.4%). 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.
Read the 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; 280:1161-1167
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 HIV/STD 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; 31(8): 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 HIV/STD risk reduction counseling. J Infect Dis 2004; 190: 1059-67.
Pealer Lisa, et al. Are Counselor Demographics Associated with Successful HIV/STD 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; 159(3): 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; 139(3): 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 Professions.2001; 4(24):363-384.
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; 28(8): 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; 28(6): 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 (3):167-173.
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; 12:357-364.
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. 2000:19;458-468
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; 6(4): 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 HIV/STD prevention counseling intervention. Sex Transm Infect 1998; 74:253-255.
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; 25(4): 222-223.
- Conditions
- HIV, Sexually Transmitted Diseases
- Being tested
- "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model, "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior, "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies
- Keywords
- voluntary counseling and testing, HIV/STD prevention counseling, HIV/STD prevention intervention, counseling efficacy
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief ModelBehavioural
"Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behaviorBehavioural
"HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategiesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startApr 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 6,000 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- San Francisco Department of Public Health, City of Long Beach Department of Health and Human Services, Colorado Department of Public Health and Environment, Baltimore City Health Department, City of Newark Health Department
- Investigators
- Mary L Kamb, MD, MPH, Principal investigator, US Centers for Disease Control and Prevention (CDC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362791
- Sponsor's protocol ID
- CDC-NCHSTP-1112.1
- Other IDs
- R30/CCR207113-03, R30/CCR307116-01, R30/CCR807114-04, R33/CCR907111-03, R30/CCR907117-03
- Status last verified
- Jul 2005
- First submitted
- 8 Aug 2006
- Last updated
- 10 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Evaluating the Efficacy of HIV/STD Prevention Counseling and Testing in Preventing High Risk Behaviors and New Sexually Transmitted Diseases (Project RESPECT)
- ClinicalTrials.gov ID
- NCT00362791
- Acronym / sponsor ID
- CDC-NCHSTP-1112.1
- Conditions
- HIV, Sexually Transmitted Diseases
- Keywords
- voluntary counseling and testing, HIV/STD prevention counseling, HIV/STD prevention intervention, counseling efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- San Francisco Department of Public Health, City of Long Beach Department of Health and Human Services, Colorado Department of Public Health and Environment, Baltimore City Health Department, City of Newark Health Department
- Study start
- Apr 2003
- Study completion
- Jul 2005
- First posted
- 10 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 HIV/STD 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 CDC's client-centered counseling model. Arms 3 and 4 each received 2 brief didactic messages about HIV/STD 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 (P<.05) 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 (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms compared with those in the didactic messages arm (10.4%). 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; 280:1161-1167
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 HIV/STD 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; 31(8): 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 HIV/STD risk reduction counseling. J Infect Dis 2004; 190: 1059-67.
Pealer Lisa, et al. Are Counselor Demographics Associated with Successful HIV/STD 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; 159(3): 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; 139(3): 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 Professions.2001; 4(24):363-384.
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; 28(8): 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; 28(6): 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 (3):167-173.
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; 12:357-364.
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. 2000:19;458-468
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; 6(4): 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 HIV/STD prevention counseling intervention. Sex Transm Infect 1998; 74:253-255.
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; 25(4): 222-223.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who came to the STD clinic and who were eligible in routine clinic practice to undergo confidential HIV testing
Key exclusion criteria (9 listed)
- residence outside the clinics' catchment areas
- had made firm plans (e.g., can give a new address) to move outside the clinic catchment area during the next 12 months
- unable to provide informed consent to be tested for HIV and take part in the follow up aspect of the study (e.g., incarcerated, mental status changes from drugs, alcohol, medication)
- reported that he or she had tested positive for HIV in the past
- did not speak and comprehend English well enough to participate in the interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model | Behavioural | – |
| "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior | Behavioural | – |
| "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary L Kamb, MD, MPH principal investigator
US Centers for Disease Control and Prevention (CDC)
Questions about this trial
What is this clinical trial studying?
A study testing "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model, "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior and "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies in people with HIV and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2006.