HIV InfectionsNCT00644163
Effectiveness of a Risk Reduction Program in Preventing the Transmission of HIV and Sexually Transmitted Diseases in African-American Couples
A study testing Eban HIV/STD Risk Reduction Intervention and Eban Health Promotion Intervention in people with HIV Infections and Sexually Transmitted Disease, run by University of Pennsylvania at 4 sites in United States.
Trial summary
This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Disease
- What is being tested?
- Eban HIV/STD Risk Reduction Intervention and Eban Health Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,070 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2003to Jun 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each partner agrees that the relationship has lasted at least 6 months before study entry
- Each partner intends to remain together for at least 12 months after study entry (e.g., state independently that he/she is confident or very confident that they will remain together)
- At least one partner of the couple reports having unprotected intercourse at least once in the 90 days before study entry
- Neither partner has plans to relocate beyond a reasonable distance from the study site
- At least one partner is African American
- At least one partner agrees that he/she is not planning pregnancy within the next 18 months after study entry
- Each partner is aware of his/her partner's HIV serostatus
- Only one partner is HIV seropositive and has known his or her status for at least 3 months before study entry
Who cannot join
- One or both partners do not have an address where they can receive mail
- One or both partners have significant psychiatric, physical, or neurological impairment that would limit their effective participation as confirmed on a Mini Mental State Examination and/or Quick Test
- History of severe physical or sexual abuse in the 1 year before study entry in the current relationship (e.g., significant enough to require medical, psychological, and/or legal intervention)
- One or both partners are unwilling or unable to commit to participate in the study through to completion
- Both partners have previously participated in an HIV sexual risk-reduction intervention for couples in the 12 months before study entry
- One or both partners are not fluent in English as determined by the informed consent process
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
UCLA
Los Angeles, California, 90024
Columbia University
New York, New York, 10027
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: NIMH Multisite HIV/STD Prevention Trial for African American Couples
This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection.
Read the detailed description
The transmission of sexually transmitted diseases (STDs), including HIV, is a major public health concern, especially among minority groups in the United States. Although STDs are prevalent across all racial and ethnic groups in the United States, the rate of STD infection is disproportionately higher for African Americans than for white Americans. African Americans have higher rates of HIV, chlamydia, gonorrhea, syphilis, and herpes than white Americans. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. Interventions are needed in a variety of settings to extensively address African Americans' risk of STDs, including HIV. Although most HIV/STD risk-reduction interventions are conducted at the individual level, a couple-based approach may be more effective and consistent with cultural values. This study will compare the effectiveness of the Eban HIV/STD Risk Reduction Intervention with the Eban Health Promotion Intervention in reducing the risk of STDs among African-American HIV-serodiscordant heterosexual couples.
Participation in this study will last 12 months. All participants will first undergo baseline assessments that will consist of questionnaires and biospecimen collection for STD testing. Participants will then be assigned randomly to one of two treatment groups: the Eban HIV/STD Risk Reduction Intervention group or the Eban Health Promotion Intervention group. Both groups will participate in weekly 2-hour sessions over 8 weeks. The sessions will include couple and group sessions led by trained male and female co-facilitators. The Eban HIV/STD Risk Reduction Intervention sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. The Eban Health Promotion Intervention sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. Follow-up visits for all participants will occur at Months 3, 6, and 12 and will include repeat baseline assessments.
- Conditions
- HIV Infections, Sexually Transmitted Disease
- Being tested
- Eban HIV/STD Risk Reduction Intervention, Eban Health Promotion Intervention
- Keywords
- HIV, STI, Risk Reduction, Couples, African American, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eban HIV/STD Risk Reduction InterventionBehavioural
The eight-session Eban HIV/STD Risk Reduction Intervention is embedded in a cultural context and is gender tailored in its prevention messages and activities. Sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations.
Eban Health Promotion InterventionBehavioural
The eight-session Eban Health Promotion Intervention is guided by a social cognitive approach that engages health promotion skills. Sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive Eban HIV/STD Risk Reduction Intervention. Receives: Behavioral: Eban HIV/STD Risk Reduction Intervention |
| 2 | Active comparator | Participants will receive Eban Health Promotion Intervention. Receives: Behavioral: Eban Health Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported proportion of condom-protected sexual intercourse
Measured: Measured at Month 12
Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)
Measured: Measured at Month 12
Secondary outcomes (2)
Unprotected sex occurrence
Measured: Measured at Month 12
Number of sexual partners
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startNov 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Parallel groups
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Los Angeles, Emory University, Columbia University
- Responsible party
- Sponsor
- Investigators
- John Jemmott, PhD, Principal investigator, University of PennsylvaniaNabila el-Bassel, DSW, Principal investigator, Columbia UniversityGail Wyatt, PhD, Principal investigator, University of California, Los AngelesGina Wingood, ScD, Principal investigator, Emory UniversityJ. Richard Landis, PhD, Principal investigator, University of Pennsylvania/Data Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644163
- Sponsor's protocol ID
- U10MH078819
- Other IDs
- U10MH078819, DAHBR 9A-ASGT
- Status last verified
- Feb 2009
- First submitted
- 24 Mar 2008
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamilton AB, Mittman BS, Williams JK, Liu HH, Eccles AM, Hutchinson CS, Wyatt GE. Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol. Implement Sci. 2014 Jun 20;9:79. doi: 10.1186/1748-5908-9-79.
PubMed 24950708El-Bassel N, Jemmott JB 3rd, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; National Institute of Mental Health Multisite HIV/STD Prevention Trial for African-American Couples Group. Intervention to influence behaviors linked to risk of chronic diseases: a multisite randomized controlled trial with African-American HIV-serodiscordant heterosexual couples. Arch Intern Med. 2011 Apr 25;171(8):728-36. doi: 10.1001/archinternmed.2011.136.
PubMed 21518939El-Bassel N, Jemmott JB, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial. Arch Intern Med. 2010 Sep 27;170(17):1594-601. doi: 10.1001/archinternmed.2010.261. Epub 2010 Jul 12.
PubMed 20625011
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIMH Multisite HIV/STD Prevention Trial for African American Couples
- ClinicalTrials.gov ID
- NCT00644163
- Acronym / sponsor ID
- U10MH078819
- Conditions
- HIV Infections, Sexually Transmitted Disease
- Keywords
- HIV, STI, Risk Reduction, Couples, African American, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Los Angeles, Emory University, Columbia University
- Study start
- Nov 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Mar 2008 (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.
This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection.
Detailed description
The transmission of sexually transmitted diseases (STDs), including HIV, is a major public health concern, especially among minority groups in the United States. Although STDs are prevalent across all racial and ethnic groups in the United States, the rate of STD infection is disproportionately higher for African Americans than for white Americans. African Americans have higher rates of HIV, chlamydia, gonorrhea, syphilis, and herpes than white Americans. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. Interventions are needed in a variety of settings to extensively address African Americans' risk of STDs, including HIV. Although most HIV/STD risk-reduction interventions are conducted at the individual level, a couple-based approach may be more effective and consistent with cultural values. This study will compare the effectiveness of the Eban HIV/STD Risk Reduction Intervention with the Eban Health Promotion Intervention in reducing the risk of STDs among African-American HIV-serodiscordant heterosexual couples.
Participation in this study will last 12 months. All participants will first undergo baseline assessments that will consist of questionnaires and biospecimen collection for STD testing. Participants will then be assigned randomly to one of two treatment groups: the Eban HIV/STD Risk Reduction Intervention group or the Eban Health Promotion Intervention group. Both groups will participate in weekly 2-hour sessions over 8 weeks. The sessions will include couple and group sessions led by trained male and female co-facilitators. The Eban HIV/STD Risk Reduction Intervention sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. The Eban Health Promotion Intervention sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. Follow-up visits for all participants will occur at Months 3, 6, and 12 and will include repeat baseline assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Eban HIV/STD Risk Reduction InterventionParticipants will receive Eban HIV/STD Risk Reduction Intervention. |
| 2 | Active comparator | Behavioral: Eban Health Promotion InterventionParticipants will receive Eban Health Promotion Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Each partner agrees that the relationship has lasted at least 6 months before study entry
- Each partner intends to remain together for at least 12 months after study entry (e.g., state independently that he/she is confident or very confident that they will remain together)
- At least one partner of the couple reports having unprotected intercourse at least once in the 90 days before study entry
- Neither partner has plans to relocate beyond a reasonable distance from the study site
- At least one partner is African American
Key exclusion criteria (6 listed)
- One or both partners do not have an address where they can receive mail
- One or both partners have significant psychiatric, physical, or neurological impairment that would limit their effective participation as confirmed on a Mini Mental State Examination and/or Quick Test
- History of severe physical or sexual abuse in the 1 year before study entry in the current relationship (e.g., significant enough to require medical, psychological, and/or legal intervention)
- One or both partners are unwilling or unable to commit to participate in the study through to completion
- Both partners have previously participated in an HIV sexual risk-reduction intervention for couples in the 12 months before study entry
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 |
|---|---|---|
| Eban HIV/STD Risk Reduction InterventionThe eight-session Eban HIV/STD Risk Reduction Intervention is embedded in a cultural context and is gender tailored in its prevention messages and activities. Sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. | Behavioural | 1 |
| Eban Health Promotion InterventionThe eight-session Eban Health Promotion Intervention is guided by a social cognitive approach that engages health promotion skills. Sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. | Behavioural | 2 |
Primary outcome
Self-reported proportion of condom-protected sexual intercourse
Time frame: Measured at Month 12
Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)
Time frame: Measured at Month 12
2 secondary outcomes
Unprotected sex occurrence
Time frame: Measured at Month 12
Number of sexual partners
Time frame: Measured at Month 12
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 27 Jan 2014.
- Derived from this study: PubMed 24950708Hamilton AB, Mittman BS, Williams JK, Liu HH, Eccles AM, Hutchinson CS, Wyatt GE. Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol. Implement Sci. 2014 Jun 20;9:79. doi: 10.1186/1748-5908-9-79.
- Derived from this study: PubMed 21518939El-Bassel N, Jemmott JB 3rd, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; National Institute of Mental Health Multisite HIV/STD Prevention Trial for African-American Couples Group. Intervention to influence behaviors linked to risk of chronic diseases: a multisite randomized controlled trial with African-American HIV-serodiscordant heterosexual couples. Arch Intern Med. 2011 Apr 25;171(8):728-36. doi: 10.1001/archinternmed.2011.136.
- Derived from this study: PubMed 20625011El-Bassel N, Jemmott JB, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL; NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial. Arch Intern Med. 2010 Sep 27;170(17):1594-601. doi: 10.1001/archinternmed.2010.261. Epub 2010 Jul 12.
Related trials for HIV Infections
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
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.
John Jemmott, PhD principal investigator
University of Pennsylvania
Nabila el-Bassel, DSW principal investigator
Columbia University
Gail Wyatt, PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eban HIV/STD Risk Reduction Intervention and Eban Health Promotion Intervention in people with HIV Infections and Sexually Transmitted Disease, run by University of Pennsylvania at 4 sites in United States.
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 8 inclusion and 6 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Self-reported proportion of condom-protected sexual intercourse (time frame: Measured at Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644163, which also lists 3 linked publications.
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 27 Jan 2014.