Tanzabilities Aim 3: Randomized Controlled Trial of a Sexual and Reproductive Health Curriculum for Persons With Disabilities
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 412
- Locations
- 2
- Primary Endpoint
- Change in Composite Knowledge Score as Assessed by the Tanzabilities Survey Instrument
Study Overview
Brief Summary
This randomized controlled trial will evaluate the efficacy of a three-day sexual and reproductive health curriculum focused on persons with disabilities and tailored to the Tanzanian context.
The intervention will be delivered to medical, nursing, and midwifery students at Muhimbili University of Health and Allied Sciences in Dar es Salaam, Tanzania. Participants will be randomized to either receive the curriculum during the initial intervention period or to a waitlist control group that will receive the curriculum approximately 12 months later.
Participants will complete surveys at baseline and at 3-month follow-up to assess changes in knowledge, attitudes, skills, comfort, and advocacy related to sexual and reproductive health care for persons with disabilities. Participants in the intervention group will also complete an immediate post-intervention survey after the three-day curriculum.
Detailed Description
People with disabilities in Tanzania experience barriers to sexual and reproductive health care, and health professional students may receive limited training on disability-inclusive sexual and reproductive health care. This study will evaluate a curriculum designed to improve health professional students' knowledge, attitudes, skills, comfort, and advocacy related to providing sexual and reproductive health care for persons with disabilities.
This study is a randomized, controlled, open-label trial of a three-day sexual and reproductive health curriculum focused on persons with disabilities. The study will enroll 412 medical, nursing, and midwifery students from Muhimbili University of Health and Allied Sciences in Dar es Salaam, Tanzania.
Participants will complete an appointment before the intervention to provide consent, complete a baseline survey, and be randomized. Randomization will be stratified by health profession. Participants will be randomized to either the intervention group or the waitlist control group.
The intervention consists of a three-day curriculum delivered by Muhimbili University of Health and Allied Sciences faculty. The curriculum includes six modules: Introduction to Sexual Health for People with Disabilities; Sexual Health Across the Lifespan for People with Disabilities; Sexual Health Concerns for People with Disabilities; Assumptions and Stigma for People with Disabilities: Reducing Barriers to Sexual and Reproductive Health Care; Ethical and Legal Frameworks for People with Disabilities; and Sexual and Reproductive Health Communication with People with Disabilities. The curriculum includes lectures, videos, discussions, role plays, case studies, and case scenarios involving people with disabilities roleplaying as patients.
Participants assigned to the intervention group will receive the curriculum during the initial intervention period. Participants assigned to the waitlist control group will complete the baseline survey and 3-month follow-up survey at the same time as the intervention group and will receive the curriculum approximately 12 months later.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
This is an open-label study. Participants and study staff will know whether participants are assigned to the intervention group or the waitlist control group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Current student at Muhimbili University of Health and Allied Sciences in midwifery, nursing, or medicine
- •Able to attend the full 3-day training
- •Fluent in English and Kiswahili
- •Willing to complete all evaluation procedures
Exclusion Criteria
- •Unable to attend all days of the seminar at Muhimbili University of Health and Allied Sciences
- •Expresses reservations about attending, including religious objections
- •Expresses fear of violence due to attending, including fear of violence from a spouse or relative
- •Prior exposure to the Training Health Professionals curriculum or either of the Tanzabilities pilots
- •Younger than 18 years of age
- •Unable to provide consent
- •Non-English speaker
- •Unable to read
- •Employee of the researcher
Arms & Interventions
Disability-Focused Sexual and Reproductive Health Curriculum
Participants assigned to this arm will receive the three-day persons with disabilities-focused sexual and reproductive health curriculum during the initial intervention period. The curriculum will be delivered by Muhimbili University of Health and Allied Sciences faculty and includes lectures, videos, discussions, role plays, case studies, and communication skills practice. Participants will complete baseline, immediate post-intervention, and 3-month follow-up surveys.
Intervention: Disability-Focused Sexual and Reproductive Health Curriculum (Behavioral)
Waitlist Control
Participants assigned to this arm will complete the baseline survey and 3-month follow-up survey at the same time as the intervention group but will not receive the curriculum during the initial intervention period. They will receive the curriculum approximately 12 months later, in August or September 2027, depending on the Muhimbili University of Health and Allied Sciences academic calendar.
Outcomes
Primary Outcomes
Change in Composite Knowledge Score as Assessed by the Tanzabilities Survey Instrument
Time Frame: Baseline, immediate post-intervention, and 3-month follow-up
Sexual and reproductive health and disability knowledge will be assessed using 36 survey items from the Tanzabilities Survey Instrument, which incorporates investigator-developed items, adapted items from the National Inclusive Curriculum for Health Education-Medical (NICHE-MED) scale, and adapted items from the Sexual Health Education for Professionals Scale (SHEPS). Twenty-two items are multiple choice, 8 items are true/false, and 6 items are Likert-scale knowledge self-assessment questions. The outcome will be calculated as a composite score of responses to knowledge-related survey questions. Scores range from 6 to 52, with higher scores indicating greater knowledge. Primary between-group comparisons will assess change from baseline to 3-month follow-up. Within the intervention group, change will also be assessed from baseline to immediate post-intervention.
Change in Composite Attitudes Score as Assessed by the Tanzabilities Survey Instrument
Time Frame: Baseline, immediate post-intervention, and 3-month follow-up
Attitudes toward the provision of sexual and reproductive health services for persons with disabilities will be assessed using 40 Likert-scale survey items from the Tanzabilities Survey Instrument, which incorporates investigator-developed items, adapted items from the National Inclusive Curriculum for Health Education-Medical (NICHE-MED) scale, and adapted items from the Sexual Health Education for Professionals Scale (SHEPS). The outcome will be calculated as a composite score of responses to attitude-related survey questions. Scores range from 40 to 200, with higher scores indicating more positive attitudes. Primary between-group comparisons will assess change from baseline to 3-month follow-up. Within the intervention group, change will also be assessed from baseline to immediate post-intervention.
Change in Composite Skills Score as Assessed by the Tanzabilities Survey Instrument
Time Frame: Baseline, immediate post-intervention, and 3-month follow-up
Skills related to providing sexual and reproductive health care to persons with disabilities will be assessed using 60 Likert-scale survey items from the Tanzabilities Survey Instrument, which incorporates investigator-developed items, adapted items from the National Inclusive Curriculum for Health Education-Medical (NICHE-MED) scale, and adapted items from the Sexual Health Education for Professionals Scale (SHEPS). The outcome will be calculated as a composite score of responses to skills-related survey questions. Scores range from 60 to 300, with higher scores indicating greater skills. Primary between-group comparisons will assess change from baseline to 3-month follow-up. Within the intervention group, change will also be assessed from baseline to immediate post-intervention.
Secondary Outcomes
- Differences in Composite Knowledge Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument(Baseline, immediate post-intervention, and 3-month follow-up)
- Differences in Composite Attitudes Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument(Baseline, immediate post-intervention, and 3-month follow-up)
- Differences in Composite Skills Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument(Baseline, immediate post-intervention, and 3-month follow-up)
- Change in Composite Advocacy Score as Assessed by the Tanzabilities Survey Instrument(Baseline, immediate post-intervention, and 3-month follow-up)