Sexual and Reproductive HealthPhase 3NCT07772778
Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania
A Phase 3 study testing Disability-Focused Sexual and Reproductive Health Curriculum in people with Sexual and Reproductive Health and Disability, run by University of Minnesota at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual and Reproductive Health, Disability, Health Knowledge, Attitudes, Practice
- What is being tested?
- Disability-Focused Sexual and Reproductive Health Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Phase 3
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Non-English speaker
- Unable to read
- Employee of the researcher
- Prisoner
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Tanzabilities Aim 3: Randomized Controlled Trial of a Sexual and Reproductive Health Curriculum for Persons With Disabilities
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.
Read the 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.
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.
- Conditions
- Sexual and Reproductive Health, Disability, Health Knowledge, Attitudes, Practice, Health Education
- Being tested
- Disability-Focused Sexual and Reproductive Health Curriculum
- Keywords
- Tanzabilities, Sexual and reproductive health, Persons with disabilities, Disability-inclusive care, Health professional students, Medical students, Dar es Salaam, Healthcare provider training
- Medical subject headings
- Coitus, Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disability-Focused Sexual and Reproductive Health CurriculumBehavioural
Also called Tanzabilities Curriculum
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.
| Study group | Role | What they receive |
|---|---|---|
| Disability-Focused Sexual and Reproductive Health Curriculum | Experimental | 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. Receives: Behavioral: Disability-Focused Sexual and Reproductive Health Curriculum |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual and Reproductive HealthStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the three-day sexual and reproductive health curriculum intervention group or a waitlist control group. The intervention group will receive the curriculum during the initial intervention period, while the waitlist control group will receive the curriculum approximately 12 months later.
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indiana University, Johns Hopkins University, Malmö University, Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Kristen Mark, PhD,MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772778
- Sponsor's protocol ID
- FMCH-2026-35163
- Other IDs
- R01HD110999
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chandan P, Noonan EJ, Brody KD, Feller C, Lauer E. Innovation in Medical Education on Intellectual/Developmental Disabilities: Report on the National Inclusive Curriculum for Health Education-Medical Initiative. Med Care. 2025 Jan 1;63(1 Suppl 1):S25-S30. doi: 10.1097/MLR.0000000000002079. Epub 2024 Dec 6.
PubMed 39642011Ross MW, Leshabari S, Rosser BRS, Trent M, Mgopa L, Wadley J, Kohli N, Agardh A. Evaluation of an assessment instrument for a sexual health curriculum for nurses and midwifery students in Tanzania: The sexual health education for professionals scale (SHEPS). Appl Nurs Res. 2018 Apr;40:152-156. doi: 10.1016/j.apnr.2018.01.005. Epub 2018 Feb 1.
PubMed 29579491