HIV InfectionsNCT00670163
Effectiveness of Community-Level Behavioral and Biomedical Interventions for Reducing HIV/STIs in Men in Peru
A study testing Enhanced Partner Therapy (EPT) and Communidades Positivas (CPOS) in people with HIV Infections and Sexually Transmitted Infections, run by University of California, Los Angeles at 1 site in Peru.
Trial summary
This study will evaluate the effectiveness of community-level behavioral and biomedical interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually transmitted infections in Peruvian men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infections
- What is being tested?
- Enhanced Partner Therapy (EPT) and Communidades Positivas (CPOS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 1 sitePeru
- Study dates
- Apr 2008to Feb 2011
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For MSM evaluation group:
- Anatomically male at birth (by self-report)
- Lives in study barrio OR works in study barrio OR socializes in study barrio (present at least 3 times per week)
- Anal or oral sexual intercourse with another male in the 12 months before study entry
- Stated preference for sexual relations with males
- For CPOS group:
- Self-identifies as a man who has sex with men
Who cannot join
- For all participants:
- Imminent plans to move away from the study barrio for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comunidades Positivas and Enhanced Partner Therapy in Peru
This study will evaluate the effectiveness of community-level behavioral and biomedical interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually transmitted infections in Peruvian men who have sex with men.
Read the detailed description
Sexually transmitted infections (STIs), including HIV, are among the most significant public health concerns worldwide. Although common across all groups of people, STIs have had a considerable impact among men who have sex with men (MSM). Particularly, in Peru, which accounts for about 6% of the estimated HIV infections in Latin America, HIV and STIs are highly concentrated in the MSM population.
Both behavioral and biomedical interventions are needed to provide education about the health risks associated with unprotected sex and to help those with STIs seek treatment. Communidades Positivas (CPOS) (Spanish for "Positive Communities") is a behavioral intervention designed to reduce the frequency of sexual activity with nonprimary partners. Enhanced partner therapy (EPT) is a biomedical intervention designed to provide treatment to partners who may become or already are infected with an STI and to thereby reduce the rate of reinfections. When implemented individually or together at a community level, these interventions may be effective in preventing HIV/STI transmission in MSM. This study will evaluate the effectiveness of community-level CPOS and EPT, each alone and combined, in reducing sexual risk behavior and HIV/STIs in Peruvian MSM.
Participation in this study will last 18 months. A total of 24 communities will be assigned randomly to 1 of 4 different treatment groups:
- Communities in Group 1 will provide CPOS plus EPT to MSM.
- Communities in Group 2 will provide CPOS alone to MSM.
- Communities in Group 3 will provide EPT alone to MSM.
- Communities in Group 4 will provide standard care to MSM.
Within each community, a select number of MSM will be evaluated at various points during the study. The initial evaluation visit will occur prior to any treatment and will include an interview, counseling, and HIV/STI testing. The interview will involve questions about health and community, including topics such as sexual activities, views on health problems, use of alcohol and drugs, use of health care services, and attitudes about people with HIV or AIDS. Counselors will then provide information about contracting and preventing HIV/STIs and will ask questions about STI symptoms. Finally, HIV/STI testing will be conducted and throat and anal swabs will be collected. Two weeks after the initial evaluation, MSM will receive their test results, and if positive for HIV or any STIs, they will receive appropriate referrals, services, and treatments. They will also receive the specific treatment to which their community was assigned and will be asked additional questions concerning the treatment of their partners, if applicable. The remaining evaluations, which will repeat assessments from the initial evaluation, will occur at months 9 and 18.
Standard care will include the care that has been established by the Peruvian national guidelines for managing HIV and STIs. In EPT, MSM will be encouraged to pass along to their recent partners packets that contain informational brochures, reference cards, prophylactic medications, and condoms. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and their partners.
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Being tested
- Enhanced Partner Therapy (EPT), Communidades Positivas (CPOS), Standard Care
- Keywords
- Men Who Have Sex With Men
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Partner Therapy (EPT)Behavioural
Also called EPT
EPT, a biomedical intervention, is designed to reduce the rate of sexually transmitted infection (STI) reinfection and, therefore, incident STIs. Men who have sex with men (MSM) with incident STIs will be given partner treatment packets that contain informational brochures, reference cards, prophylactic medications, and condoms for their sexual partners.
Communidades Positivas (CPOS)Behavioural
Also called CPOS
The behavioral intervention, CPOS, is based on a combination of social-action theory and diffusion of innovation and is designed to reduce the frequency of unprotected sex with nonprimary partners. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and partners. CPOS will include a training program of at least 14 sessions. During these sessions, MSM leaders will be provided with information about HIV/STIs and their prevention and ways to strengthen leadership skills. The 2-hour group sessions will occur two times a week for 7 weeks. While the training sessions are underway, MSM leaders will be asked to work with community leaders to form a community center from which they will carry out HIV/STI prevention and promotion of sexual health activities for 18 months.
Standard CareBehavioural
Standard care will consist of usual care for STIs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participating community will provide Comunidades Positivas plus enhanced partner therapy. Receives: Behavioral: Enhanced Partner Therapy (EPT); Behavioral: Communidades Positivas (CPOS) |
| 2 | Experimental | Participating community will provide enhanced partner therapy alone. Receives: Behavioral: Enhanced Partner Therapy (EPT) |
| 3 | Experimental | Participating community will provide Comunidades Positivas alone. Receives: Behavioral: Communidades Positivas (CPOS) |
| 4 | Active comparator | Participating community will provide standard of care. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of STIs
Measured: Measured at Month 18
Secondary outcomes (1)
Rates of unprotected intercourse with nonprimary partners
Measured: Measured at Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 California, Los AngelesThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas J. Coates, University of California, Los Angeles
- Investigators
- Thomas J. Coates, PhD, Principal investigator, The University of California, Los Angeles (UCLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670163
- Sponsor's protocol ID
- R01MH078752
- Other IDs
- R01MH078752, DAHBR 9A-ASGP
- Status last verified
- Dec 2013
- First submitted
- 29 Apr 2008
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leon SR, Segura ER, Konda KA, Flores JA, Silva-Santisteban A, Galea JT, Coates TJ, Klausner JD, Caceres CF. High prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infections in anal and pharyngeal sites among a community-based sample of men who have sex with men and transgender women in Lima, Peru. BMJ Open. 2016 Jan 6;6(1):e008245. doi: 10.1136/bmjopen-2015-008245.
PubMed 26739719
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comunidades Positivas and Enhanced Partner Therapy in Peru
- ClinicalTrials.gov ID
- NCT00670163
- Acronym / sponsor ID
- R01MH078752
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Keywords
- Men Who Have Sex With Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 May 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 community-level behavioral and biomedical interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually transmitted infections in Peruvian men who have sex with men.
Detailed description
Sexually transmitted infections (STIs), including HIV, are among the most significant public health concerns worldwide. Although common across all groups of people, STIs have had a considerable impact among men who have sex with men (MSM). Particularly, in Peru, which accounts for about 6% of the estimated HIV infections in Latin America, HIV and STIs are highly concentrated in the MSM population.
Both behavioral and biomedical interventions are needed to provide education about the health risks associated with unprotected sex and to help those with STIs seek treatment. Communidades Positivas (CPOS) (Spanish for "Positive Communities") is a behavioral intervention designed to reduce the frequency of sexual activity with nonprimary partners. Enhanced partner therapy (EPT) is a biomedical intervention designed to provide treatment to partners who may become or already are infected with an STI and to thereby reduce the rate of reinfections. When implemented individually or together at a community level, these interventions may be effective in preventing HIV/STI transmission in MSM. This study will evaluate the effectiveness of community-level CPOS and EPT, each alone and combined, in reducing sexual risk behavior and HIV/STIs in Peruvian MSM.
Participation in this study will last 18 months. A total of 24 communities will be assigned randomly to 1 of 4 different treatment groups:
- Communities in Group 1 will provide CPOS plus EPT to MSM.
- Communities in Group 2 will provide CPOS alone to MSM.
- Communities in Group 3 will provide EPT alone to MSM.
- Communities in Group 4 will provide standard care to MSM.
Within each community, a select number of MSM will be evaluated at various points during the study. The initial evaluation visit will occur prior to any treatment and will include an interview, counseling, and HIV/STI testing. The interview will involve questions about health and community, including topics such as sexual activities, views on health problems, use of alcohol and drugs, use of health care services, and attitudes about people with HIV or AIDS. Counselors will then provide information about contracting and preventing HIV/STIs and will ask questions about STI symptoms. Finally, HIV/STI testing will be conducted and throat and anal swabs will be collected. Two weeks after the initial evaluation, MSM will receive their test results, and if positive for HIV or any STIs, they will receive appropriate referrals, services, and treatments. They will also receive the specific treatment to which their community was assigned and will be asked additional questions concerning the treatment of their partners, if applicable. The remaining evaluations, which will repeat assessments from the initial evaluation, will occur at months 9 and 18.
Standard care will include the care that has been established by the Peruvian national guidelines for managing HIV and STIs. In EPT, MSM will be encouraged to pass along to their recent partners packets that contain informational brochures, reference cards, prophylactic medications, and condoms. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and their partners.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Enhanced Partner Therapy (EPT), Behavioral: Communidades Positivas (CPOS)Participating community will provide Comunidades Positivas plus enhanced partner therapy. |
| 2 | Experimental | Behavioral: Enhanced Partner Therapy (EPT)Participating community will provide enhanced partner therapy alone. |
| 3 | Experimental | Behavioral: Communidades Positivas (CPOS)Participating community will provide Comunidades Positivas alone. |
| 4 | Active comparator | Behavioral: Standard CareParticipating community will provide standard of care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Anatomically male at birth (by self-report)
- Lives in study barrio OR works in study barrio OR socializes in study barrio (present at least 3 times per week)
- Anal or oral sexual intercourse with another male in the 12 months before study entry
- Stated preference for sexual relations with males
- Self-identifies as a man who has sex with men
Key exclusion criteria (2 listed)
- Imminent plans to move away from the study barrio for the duration of the study
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 Partner Therapy (EPT)Also: EPTEPT, a biomedical intervention, is designed to reduce the rate of sexually transmitted infection (STI) reinfection and, therefore, incident STIs. Men who have sex with men (MSM) with incident STIs will be given partner treatment packets that contain informational brochures, reference cards, prophylactic medications, and condoms for their sexual partners. | Behavioural | 1, 2 |
| Communidades Positivas (CPOS)Also: CPOSThe behavioral intervention, CPOS, is based on a combination of social-action theory and diffusion of innovation and is designed to reduce the frequency of unprotected sex with nonprimary partners. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and partners. CPOS will include a training program of at least 14 sessions. During these sessions, MSM leaders will be provided with information about HIV/STIs and their prevention and ways to strengthen leadership skills. The 2-hour group sessions will occur two times a week for 7 weeks. While the training sessions are underway, MSM leaders will be asked to work with community leaders to form a community center from which they will carry out HIV/STI prevention and promotion of sexual health activities for 18 months. | Behavioural | 1, 3 |
| Standard CareStandard care will consist of usual care for STIs. | Behavioural | 4 |
Primary outcome
Cumulative incidence of STIs
Time frame: Measured at Month 18
1 secondary outcome
Rates of unprotected intercourse with nonprimary partners
Time frame: Measured at Month 18
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 13 Dec 2013.
- Derived from this study: PubMed 26739719Leon SR, Segura ER, Konda KA, Flores JA, Silva-Santisteban A, Galea JT, Coates TJ, Klausner JD, Caceres CF. High prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infections in anal and pharyngeal sites among a community-based sample of men who have sex with men and transgender women in Lima, Peru. BMJ Open. 2016 Jan 6;6(1):e008245. doi: 10.1136/bmjopen-2015-008245.
Related trials for HIV Infections
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Enrolling by invitation
ORCHID: An Online Intervention for Persons With HIV (Miami)
HIV/AIDS, HPV Infection
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.
Thomas J. Coates, PhD principal investigator
The University of California, Los Angeles (UCLA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Partner Therapy (EPT) and Communidades Positivas (CPOS) in people with HIV Infections and Sexually Transmitted Infections, run by University of California, Los Angeles at 1 site in Peru.
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 7 inclusion and 2 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 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. 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?
Cumulative incidence of STIs (time frame: Measured at Month 18). 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 NCT00670163, which also lists 1 linked publication.
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 13 Dec 2013; AzTrials last refreshed its copy on 1 Nov 2026.