SustainabilityNCT07153042
Sustainability and Precision Prevention Project
A study testing Biweekly monitoring and feedback (BMF), Site-based assistance and mentorship (SAM) and Enhanced site-based assistance and mentorship (Enhanced SAM) in people with Sustainability, run by University of Massachusetts, Worcester at 1 site in The Bahamas.
Trial summary
This is a five-year hybrid type 3 effectiveness-implementation study evaluating multilevel strategies to sustain a nationwide implementation of an evidence-based HIV prevention curriculum in schools. Advanced machine learning methods are being used to enhance implementation strategies. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Sustainability
- What is being tested?
- Biweekly monitoring and feedback (BMF), Site-based assistance and mentorship (SAM) and Enhanced site-based assistance and mentorship (Enhanced SAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,705 participants
- Where
- 1 siteThe Bahamas
- Study dates
- 1 Oct 2025to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Grade 6 teachers who teach Health and Family Life Education (HFLE) and their classes in 65 government primary schools.
- Grade 7-9 HFLE teachers and their classes in 30 middle schools across 12 Bahamian islands.
- FOYC (Focus on Youth in the Caribbean) is delivered as part of the standard HFLE curriculum.
- Students who: 1) are enrolled in one of the participating schools as general education students in grade 6 (and followed through grades 7-9); and 2) speak and read English.
Who cannot join
- Students who chose to opt out of participating in the study
- Students who do not speak or read English sufficiently to participate in study activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deogwoon Kim, PhD contact
The Bahamas1 site, 1 recruiting
- Recruiting
HIV/AIDS Office, FOY program
Nassau
Lynette Deveaux, 1-242-454-8488, lyndeveaux@yahoo.com
About this study
Official title: National Implementation of an Evidence-Based HIV Prevention Program: Multilevel Scale-Up Strategies and Precision Prevention
This is a five-year hybrid type 3 effectiveness-implementation study evaluating multilevel strategies to sustain a nationwide implementation of an evidence-based HIV prevention curriculum in schools. Advanced machine learning methods are being used to enhance implementation strategies. A Sequential, Multiple Assignment, Randomized Trial (SMART) design will be employed.
Read the detailed description
A hybrid type 3 effectiveness-implementation study is proposed, using a SMART adaptive implementation trial that will evaluate the value of multilevel strategies to sustain Focus on Youth in Caribbean + Caribbean Informed Parents and Children Together (FOYC+CImPACT) in schools and harness advanced machine learning to help promote the FOYC+CImPACT sustainability by iteratively enriching implementation strategies. This study will also identify the most effective implementation strategy for teachers who implement <80% of core activities and for adolescents who are unlikely to respond to FOYC+CImPACT by using machine learning approaches. The primary outcome is program sustainability. Data from teachers, students, and focus groups will provide information on inner and outer contexts, strategies to promote implementation and sustainability, and program effectiveness.
Primary implementation of FOYC+CImPACT will be conducted by 156 grade-6 teachers in 65 government primary schools across four years. Annual FOYC booster sessions for students will be conducted by 49 Health and Family Life Education (HFLE) teachers in 30 junior high schools. Approximately 3,500 students will complete the full curricular assessment survey at the beginning and end of grade 6 and at the end of grades 7, 8, and 9.
- Conditions
- Sustainability
- Being tested
- Biweekly monitoring and feedback (BMF), Site-based assistance and mentorship (SAM), Enhanced site-based assistance and mentorship (Enhanced SAM), FOYC+CImPACT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biweekly monitoring and feedback (BMF)Behavioural
School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers.
Site-based assistance and mentorship (SAM)Behavioural
High-performing teachers will serve as team leaders and guide non-responding teachers on preparation and planning. The team leader will promote group activities and enhance interaction among teachers in these meetings.
Enhanced site-based assistance and mentorship (Enhanced SAM)Behavioural
A FOYC coach (with FOYC implementation and training experience) will provide tailored in-person support, facilitate goal-setting, opportunities to interact with consultants, supportive text messaging, continuing education, networking strategies, and monthly check-ins.
FOYC+CImPACTBehavioural
Focus on Youth in the Caribbean (FOYC) is an evidence-based, eight-session life skills curriculum designed to reduce risk-taking behaviors related to HIV/STI transmission and teen pregnancy. Woven throughout FOYC is a decision-making model that provides guidance and practice in problem solving with a focus on how to obtain factual information on sexual health.
CImPACT is a single-session intervention including a 24-min educational video filmed in The Bahamas. The video focuses on effective parent-adolescent communication and listening strategies related to difficult topics including "safe-sex" followed by two role-plays for the parent and youth, a discussion, and a condom demonstration.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Experimental | All grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1). Receives: Behavioral: FOYC+CImPACT |
| Stage 2 | Experimental | Based on their performance in Year 1, teachers who do not meet the benchmark (implementing > 80% of core activities) will be randomized to receive 1) "Biweekly Monitoring and Feedback (BMF)" or 2) "BMF+Site-Based Assistance Mentorship (SAM)." Responders (completing at least 80% of core activities) will continue with UI. Receives: Behavioral: Biweekly monitoring and feedback (BMF); Behavioral: Site-based assistance and mentorship (SAM); Behavioral: FOYC+CImPACT |
| Stage 3 | Experimental | At the end of Year 2 (stage 2), the performance of the teachers in all three intervention arms will be assessed again. Non-responders in the UI arm will be re-randomized to receive either BMF or BMF+SAM. Non-responders in the BMF-only group will be re-randomized to receive BMF+SAM or BMF+enhanced SAM. Non-responders in the BMF+SAM group will receive BMF+enhanced SAM. Receives: Behavioral: Biweekly monitoring and feedback (BMF); Behavioral: Site-based assistance and mentorship (SAM); Behavioral: Enhanced site-based assistance and mentorship (Enhanced SAM); Behavioral: FOYC+CImPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity of Implementation
Adherence to the core activities (number of core activities taught as intended)
Measured: Years 1, 2, 3, and 4
Sustainability
Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years
Measured: Year 4
Sustainment determinants
The Sustainment Measurement System Scale (SMSS) is a 35-item instrument that evaluates sustainment determinants and outcomes (one sustainment outcome subscale and seven determinant domain subscales).
Items are rated on a 5-point scale, from 1 = Little or no extent to 5 = Great extent.
Subscale scores are calculated as the average of the items within the subscale, ranging from 1 to 5. Higher scores on all subscales indicate greater agreement with the subscale.
Measured: Years 1 and 3
Inner and outer context factors affecting implementation
The Program Sustainability Assessment Tools (PSAT) is an eight-domain, 40-item instrument that assesses a program's capacity for sustainability.
Items are rated on a 7-point scale from 1 = Little or no extent to 7 = A very great extent.
Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 1-7). Higher scores indicate a great level of sustainability capacity.
Measured: Yeasr 1 and 3
School implementation climate
The School Implementation Climate Scale (SICS) is a seven-domain, 21-item instrument assessing a school's climate for implementing an evidence-based practice.
Items are rated on a 5-point scale (0 = Not at all; 4 = Very great extent). Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 0-4). Higher scores indicate a more favorable implementation climate.
Measured: Years 1 and 3
Condom use skills
The Condom-Use Skills Checklist is an 8-item scale assessing youth's understanding of correct condom use.
Each item is answered True/False. Scores are calculated as the total number of correct responses. Scores range from 0 to 8, with higher scores indicating greater knowledge of condom-use skills.
Measured: Years 1, 2, 3, and 4
Self-efficacy
A 5-item self-efficacy for condom use scale will be utilized to assess students' self-perceived ability to use condoms.
Items are rated on a 5-point scale (1 = Strongly disagree; 5 = Strongly agree). Scores are calculated as the average of all items, with a range of 1 to 5. Higher scores indicate greater self-efficacy for condom use.
Measured: Years 1, 2, 3, and 4
Condom use
Self-reported condom use in the last sexual intercourse and frequency of condom use in general (always, often, sometimes, or never)
Measured: Years 1, 2, 3, and 4
Secondary outcomes (3)
Youth risk and protective behaviors
The Health-Risk and Protective Factors (HRPF) survey
Measured: Years 1, 2, and 4
Youth sensation seeking
The Health-Risk and Protective Factors (HRPF) survey
Measured: Years 1, 2, 3, and 4
Neighborhood risk
The Health-Risk and Protective Factors (HRPF) survey
Measured: Years 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SustainabilityStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ministry of Health, Bahamas
- Responsible party
- Principal investigator, Bo Wang, University of Massachusetts, Worcester
- Investigators
- Bo Wang, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153042
- Sponsor's protocol ID
- STUDY00002463
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Implementation of an Evidence-Based HIV Prevention Program: Multilevel Scale-Up Strategies and Precision Prevention
- ClinicalTrials.gov ID
- NCT07153042
- Acronym / sponsor ID
- STUDY00002463
- Conditions
- Sustainability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,705 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ministry of Health, Bahamas
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 3 Sep 2025 (actual)
- 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 is a five-year hybrid type 3 effectiveness-implementation study evaluating multilevel strategies to sustain a nationwide implementation of an evidence-based HIV prevention curriculum in schools. Advanced machine learning methods are being used to enhance implementation strategies. A Sequential, Multiple Assignment, Randomized Trial (SMART) design will be employed.
Detailed description
A hybrid type 3 effectiveness-implementation study is proposed, using a SMART adaptive implementation trial that will evaluate the value of multilevel strategies to sustain Focus on Youth in Caribbean + Caribbean Informed Parents and Children Together (FOYC+CImPACT) in schools and harness advanced machine learning to help promote the FOYC+CImPACT sustainability by iteratively enriching implementation strategies. This study will also identify the most effective implementation strategy for teachers who implement <80% of core activities and for adolescents who are unlikely to respond to FOYC+CImPACT by using machine learning approaches. The primary outcome is program sustainability. Data from teachers, students, and focus groups will provide information on inner and outer contexts, strategies to promote implementation and sustainability, and program effectiveness.
Primary implementation of FOYC+CImPACT will be conducted by 156 grade-6 teachers in 65 government primary schools across four years. Annual FOYC booster sessions for students will be conducted by 49 Health and Family Life Education (HFLE) teachers in 30 junior high schools. Approximately 3,500 students will complete the full curricular assessment survey at the beginning and end of grade 6 and at the end of grades 7, 8, and 9.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Behavioral: FOYC+CImPACTAll grade six teachers will go through the Usual Implementation (UI) of FOYC+CImPACT (teacher training only in Year 1). |
| Stage 2 | Experimental | Behavioral: Biweekly monitoring and feedback (BMF), Behavioral: Site-based assistance and mentorship (SAM), Behavioral: FOYC+CImPACTBased on their performance in Year 1, teachers who do not meet the benchmark (implementing > 80% of core activities) will be randomized to receive 1) "Biweekly Monitoring and Feedback (BMF)" or 2) "BMF+Site-Based Assistance Mentorship (SAM)." Responders (completing at least 80% of core activities) will continue with UI. |
| Stage 3 | Experimental | Behavioral: Biweekly monitoring and feedback (BMF), Behavioral: Site-based assistance and mentorship (SAM), Behavioral: Enhanced site-based assistance and mentorship (Enhanced SAM), Behavioral: FOYC+CImPACTAt the end of Year 2 (stage 2), the performance of the teachers in all three intervention arms will be assessed again. Non-responders in the UI arm will be re-randomized to receive either BMF or BMF+SAM. Non-responders in the BMF-only group will be re-randomized to receive BMF+SAM or BMF+enhanced SAM. Non-responders in the BMF+SAM group will receive BMF+enhanced SAM. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Grade 6 teachers who teach Health and Family Life Education (HFLE) and their classes in 65 government primary schools.
- Grade 7-9 HFLE teachers and their classes in 30 middle schools across 12 Bahamian islands.
- FOYC (Focus on Youth in the Caribbean) is delivered as part of the standard HFLE curriculum.
- Students who: 1) are enrolled in one of the participating schools as general education students in grade 6 (and followed through grades 7-9); and 2) speak and read English.
Key exclusion criteria (2 listed)
- Students who chose to opt out of participating in the study
- Students who do not speak or read English sufficiently to participate in study activities.
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 |
|---|---|---|
| Biweekly monitoring and feedback (BMF)School coordinators will monitor teachers' implementation progress biweekly and provide feedback to teachers. | Behavioural | Stage 2, Stage 3 |
| Site-based assistance and mentorship (SAM)High-performing teachers will serve as team leaders and guide non-responding teachers on preparation and planning. The team leader will promote group activities and enhance interaction among teachers in these meetings. | Behavioural | Stage 2, Stage 3 |
| Enhanced site-based assistance and mentorship (Enhanced SAM)A FOYC coach (with FOYC implementation and training experience) will provide tailored in-person support, facilitate goal-setting, opportunities to interact with consultants, supportive text messaging, continuing education, networking strategies, and monthly check-ins. | Behavioural | Stage 3 |
| FOYC+CImPACTFocus on Youth in the Caribbean (FOYC) is an evidence-based, eight-session life skills curriculum designed to reduce risk-taking behaviors related to HIV/STI transmission and teen pregnancy. Woven throughout FOYC is a decision-making model that provides guidance and practice in problem solving with a focus on how to obtain factual information on sexual health. CImPACT is a single-session intervention including a 24-min educational video filmed in The Bahamas. The video focuses on effective parent-adolescent communication and listening strategies related to difficult topics including "safe-sex" followed by two role-plays for the parent and youth, a discussion, and a condom demonstration. | Behavioural | Stage 1, Stage 2, Stage 3 |
Primary outcome
Fidelity of Implementation
Time frame: Years 1, 2, 3, and 4
Adherence to the core activities (number of core activities taught as intended)
Sustainability
Time frame: Year 4
Teachers' continued implementation of the intervention with fidelity (at least 80% of core activities) and adherence to program principles across 4 years
Sustainment determinants
Time frame: Years 1 and 3
The Sustainment Measurement System Scale (SMSS) is a 35-item instrument that evaluates sustainment determinants and outcomes (one sustainment outcome subscale and seven determinant domain subscales). Items are rated on a 5-point scale, from 1 = Little or no extent to 5 = Great extent. Subscale scores are calculated as the average of the items within the subscale, ranging from 1 to 5. Higher scores on all subscales indicate greater agreement with the subscale.
Inner and outer context factors affecting implementation
Time frame: Yeasr 1 and 3
The Program Sustainability Assessment Tools (PSAT) is an eight-domain, 40-item instrument that assesses a program's capacity for sustainability. Items are rated on a 7-point scale from 1 = Little or no extent to 7 = A very great extent. Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 1-7). Higher scores indicate a great level of sustainability capacity.
School implementation climate
Time frame: Years 1 and 3
The School Implementation Climate Scale (SICS) is a seven-domain, 21-item instrument assessing a school's climate for implementing an evidence-based practice. Items are rated on a 5-point scale (0 = Not at all; 4 = Very great extent). Scores are first averaged within each domain, and an overall sustainability score is calculated by averaging the domain scores (range: 0-4). Higher scores indicate a more favorable implementation climate.
Condom use skills
Time frame: Years 1, 2, 3, and 4
The Condom-Use Skills Checklist is an 8-item scale assessing youth's understanding of correct condom use. Each item is answered True/False. Scores are calculated as the total number of correct responses. Scores range from 0 to 8, with higher scores indicating greater knowledge of condom-use skills.
Self-efficacy
Time frame: Years 1, 2, 3, and 4
A 5-item self-efficacy for condom use scale will be utilized to assess students' self-perceived ability to use condoms. Items are rated on a 5-point scale (1 = Strongly disagree; 5 = Strongly agree). Scores are calculated as the average of all items, with a range of 1 to 5. Higher scores indicate greater self-efficacy for condom use.
Condom use
Time frame: Years 1, 2, 3, and 4
Self-reported condom use in the last sexual intercourse and frequency of condom use in general (always, often, sometimes, or never)
3 secondary outcomes
Youth risk and protective behaviors
Time frame: Years 1, 2, and 4
Youth sensation seeking
Time frame: Years 1, 2, 3, and 4
Neighborhood risk
Time frame: Years 1, 2, 3, and 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD collected during the trial, after deidentification.
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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.
Deogwoon Kim, PhD contact
Bo Wang, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biweekly monitoring and feedback (BMF), Site-based assistance and mentorship (SAM) and Enhanced site-based assistance and mentorship (Enhanced SAM) in people with Sustainability, run by University of Massachusetts, Worcester at 1 site in The Bahamas.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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 The Bahamas. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynette Deveaux (1-242-454-8488, lyndeveaux@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of Implementation (time frame: Years 1, 2, 3, and 4). The study lists 8 primary outcomes in all. 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 24 Sep 2026.