NCT07772778

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P50-P75 for phase_3

Timeline
12mo left

Started Sep 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

August 6, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

August 6, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

TanzabilitiesSexual and reproductive healthPersons with disabilitiesDisability-inclusive careHealth professional studentsMedical studentsDar es SalaamHealthcare provider training

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    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

Study Arms (2)

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.

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.

Interventions

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
Disability-Focused Sexual and Reproductive Health Curriculum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (2)

  • 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.

    PMID: 39642011BACKGROUND
  • Ross 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.

    PMID: 29579491BACKGROUND

MeSH Terms

Conditions

CoitusBehaviorHealth Education

Condition Hierarchy (Ancestors)

Sexual BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Kristen Mark, PhD,MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 19, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations