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Effectiveness of Community-Level Behavioral and Biomedical Interventions for Reducing HIV/STIs in Men in Peru

11 dicembre 2013 aggiornato da: Thomas J. Coates, University of California, Los Angeles

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

718

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Lima, Perù, 18
        • Universidad Peruana Cayetano Heredia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

For all participants:

  • Imminent plans to move away from the study barrio for the duration of the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Participating community will provide Comunidades Positivas plus enhanced partner therapy.
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.
Altri nomi:
  • EPT
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.
Altri nomi:
  • CPOS
Sperimentale: 2
Participating community will provide enhanced partner therapy alone.
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.
Altri nomi:
  • EPT
Sperimentale: 3
Participating community will provide Comunidades Positivas alone.
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.
Altri nomi:
  • CPOS
Comparatore attivo: 4
Participating community will provide standard of care.
Standard care will consist of usual care for STIs.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Cumulative incidence of STIs
Lasso di tempo: Measured at Month 18
Measured at Month 18

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Rates of unprotected intercourse with nonprimary partners
Lasso di tempo: Measured at Month 18
Measured at Month 18

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Thomas J. Coates, PhD, The University of California, Los Angeles (UCLA)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2008

Completamento primario (Effettivo)

1 febbraio 2011

Completamento dello studio (Effettivo)

1 febbraio 2011

Date di iscrizione allo studio

Primo inviato

29 aprile 2008

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2008

Primo Inserito (Stima)

1 maggio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 dicembre 2013

Ultimo verificato

1 dicembre 2013

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • R01MH078752 (Sovvenzione/contratto NIH degli Stati Uniti)
  • DAHBR 9A-ASGP

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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