HIV PreventionSEPA IIINCT02405481
SEPA III: The Effectiveness Trial
A study testing SEPA III in people with HIV Prevention, run by University of Miami at 1 site in United States.
Trial summary
The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- SEPA III
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2016
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hispanic Women,
- 18 to 50 years old,
- Sexually active in the past three months
Who cannot join
- Non-Hispanic,
- younger than 18,
- older than 50,
- not sexually active
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.
- Conditions
- HIV Prevention
- Being tested
- SEPA III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEPA IIIBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Wait List Control | No intervention | Not described |
| SEPA III Intervention | Experimental | SEPA brings together two important theoretical perspectives that will be effective and sustainable for HIV/AIDS prevention among Hispanic women in an inner city environment. The content and learning strategies of SEPA are based on the social cognitive theory and of HIV/AIDS prevention that prior research has shown to be the most effective in increasing HIV/AIDS prevention behaviors, modified to take into account the special needs of Hispanic women related to gender inequality and cultural values and practices. SEPA's conceptual framework integrates the Social Cognitive Model of behavioral change with Freire's Pedagogy of the Oppressed that guides the delivery and contextual tailoring. Receives: Behavioral: SEPA III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom Use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilda Peragallo Montano, University of Miami
- Investigators
- Nilda Peragallo Montano, DrPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405481
- Sponsor's protocol ID
- 20120037
- Acronym
- SEPA III
- Status last verified
- May 2018
- First submitted
- 24 Mar 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEPA III: The Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02405481
- Acronym / sponsor ID
- SEPA III / 20120037
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Apr 2015 (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 study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait List Control | No intervention | – |
| SEPA III Intervention | Experimental | Behavioral: SEPA IIISEPA brings together two important theoretical perspectives that will be effective and sustainable for HIV/AIDS prevention among Hispanic women in an inner city environment. The content and learning strategies of SEPA are based on the social cognitive theory and of HIV/AIDS prevention that prior research has shown to be the most effective in increasing HIV/AIDS prevention behaviors, modified to take into account the special needs of Hispanic women related to gender inequality and cultural values and practices. SEPA's conceptual framework integrates the Social Cognitive Model of behavioral change with Freire's Pedagogy of the Oppressed that guides the delivery and contextual tailoring. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hispanic Women,
- 18 to 50 years old,
- Sexually active in the past three months
Key exclusion criteria (4 listed)
- Non-Hispanic,
- younger than 18,
- older than 50,
- not sexually active
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 |
|---|---|---|
| SEPA III | Behavioural | SEPA III Intervention |
Primary outcome
Condom Use
Time frame: 1 year
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 22 May 2018.
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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.
Nilda Peragallo Montano, DrPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEPA III in people with HIV Prevention, run by University of Miami at 1 site 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 3 inclusion and 4 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 22 May 2018. 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 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?
Condom Use (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 22 May 2018.