A Phase 3 interventional study of Disability-Focused Sexual and Reproductive Health Curriculum in Sexual and Reproductive Health, Disability and Health Knowledge, Attitudes, Practice, sponsored by University of Minnesota. Active, not recruiting at 1 site in Tanzania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Minnesota · Phase 3, Interventional, and Other
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.
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.
The primary outcomes are changes in knowledge, attitudes, and skills related to sexual and reproductive health care for persons with disabilities. Secondary outcomes include differences by health discipline and changes in advocacy tendencies related to sexual and reproductive health and disability. Survey data will be collected at baseline and 3-month follow-up, with an immediate post-intervention survey collected from the intervention group after completion of the curriculum.
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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.
Behavioral: Disability-Focused Sexual and Reproductive Health Curriculum
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.
The intervention is a three-day curriculum focused on sexual and reproductive health care for persons with disabilities and tailored to the Tanzanian context. 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. Teaching activities include lectures, videos, discussions, role plays, case studies, and case scenarios involving people with disabilities roleplaying as patients.
Also known as: Tanzabilities Curriculum
Change in Composite Knowledge Score as Assessed by the Tanzabilities Survey Instrument
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.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in Composite Attitudes Score as Assessed by the Tanzabilities Survey Instrument
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.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in Composite Skills Score as Assessed by the Tanzabilities Survey Instrument
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.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Differences in Composite Knowledge Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument
Differences in composite knowledge scores between medical, nursing, and midwifery students will be assessed by calculating and comparing group composite knowledge scores for each discipline (medical, nursing, and midwifery) within the intervention group. The composite knowledge score (range 6 to 52, as defined in Primary Outcome Measure 1 and drawn from the Tanzabilities Survey Instrument will be analyzed across health disciplines to evaluate baseline differences and changes across all three timepoints (baseline, immediate post-intervention, and 3-month follow-up).Composite scores will be compared across medical, nursing, and midwifery students within the intervention group across baseline, immediate post-intervention, and 3-month follow-up.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Differences in Composite Attitudes Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument
Differences in composite attitudes scores between medical, nursing, and midwifery students will be assessed by calculating and comparing group composite attitudes scores for each discipline (medical, nursing, and midwifery) within the intervention group. The composite attitudes score (range 40 to 200, as defined in Primary Outcome Measure 2 and drawn from thTanzabilities Survey Instrument will be analyzed across health disciplines to evaluate baseline differences and changes across all three timepoints (baseline, immediate post-intervention, and 3-month follow-up).Composite scores will be compared across medical, nursing, and midwifery students within the intervention group across baseline, immediate post-intervention, and 3-month follow-up.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Differences in Composite Skills Scores by Health Discipline as Assessed by the Tanzabilities Survey Instrument
Differences in composite skills scores between medical, nursing, and midwifery students will be assessed by calculating and comparing group composite skills scores for each discipline (medical, nursing, and midwifery) within the intervention group. The composite skills score (range 60 to 300, as defined in Primary Outcome Measure 3 and drawn from the Tanzabilities Survey Instrument will be analyzed across health disciplines to evaluate baseline differences and changes across all three timepoints (baseline, immediate post-intervention, and 3-month follow-up). Composite scores will be compared across medical, nursing, and midwifery students within the intervention group across baseline, immediate post-intervention, and 3-month follow-up.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in Composite Advocacy Score as Assessed by the Tanzabilities Survey Instrument
Advocacy tendencies related to sexual and reproductive health and disability will be assessed using 11 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 advocacy-related survey questions. Scores range from 11 to 55, with higher scores indicating greater advocacy tendencies. Composite scores will be compared across medical, nursing, and midwifery students within the intervention group across baseline, immediate post-intervention, and 3-month follow-up.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
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