NCT03923582

Brief Summary

The goal of this randomized, controlled, single blinded trial is to evaluate the effectiveness of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health care in Tanzania.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
2 countries

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 1, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

August 7, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

August 1, 2018

Results QC Date

December 6, 2023

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in Sexual Health Knowledge Score From Baseline to Follow-up

    Sexual health knowledge was assessed using 16 multichoice items created by the research team. The items covered female sexual health concerns (2 items), sexual development and masturbation (3 items), sexual orientation (3 items), sexual violence (3 items), sexuality in middle age (3 items), sexual history taking and sexual counseling (2 items). Total scores were used for analysis (maximum total score of 16). Participants get one point for every item they answer correctly. Because there are 16 items in this section, participants can have a minimum total score of 0 and a maximum total score of 16. A higher score signifies better sexual health knowledge. A single value was calculated for the intervention arm and waitlist control from difference scores (calculated as follow-up minus baseline scores).

    At Baseline and 3-4 months Follow-up

  • Change in Sexual Health Attitudes: Confidence in Ability to Discuss From Baseline to Follow-up

    Confidence in their ability to discuss the sexual health of patients, and confidence in their ability to discuss their patients' sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in the ability to discuss sexual health topics. A single value was calculated for the intervention arm and waitlist control from difference scores (calculated as follow-up minus baseline scores).

    At Baseline and 3-4 months Follow-up

  • Change in Sexual Health Attitudes: Confidence in Having Knowledge From Baseline to Follow-up

    Confidence in their knowledge to assess the sexual health of patients, and confidence in their ability to discuss their patient's sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in having knowledge of sexual health topics. A single value was calculated for the intervention arm and waitlist control from difference scores (calculated as follow-up minus baseline scores).

    At Baseline and 3-4 months Follow-up

  • Change in Sexual Counseling Skills: Interpersonal Communications From Baseline to Follow-up

    Skills were assessed by faculty raters assessing two videos (per each time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Each participant was rated on 10 items assessing their interpersonal communication (IC) abilities. Each item was on a 3-point scale (0=not done; 1=partially done; 2=done). The scale has a minimum score of 0 and a maximum score of 20 per video. We aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 40. A higher score value signifies better interpersonal communication skills. A single value was calculated for the intervention arm and waitlist control from difference scores based on the sum of the scores at baseline and the sum of the scores at followup.

    At Baseline and 3-4 months Follow-up

  • Change in Sexual Counseling Skills: Medical History Taking From Baseline to Follow-up

    Skills were assessed by faculty raters assessing the two videos (per time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Medical history taking (MHT) was rated by six key pieces of information on a 2-point scale, where 0=not obtained information and 1=obtained information. The scale has a minimum score of 0 and a maximum score or 6 per video. We aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 12. A higher score value signifies better medical history taking skills. A single value was calculated for the intervention arm and waitlist control from difference scores based on the sum of the scores at baseline and the sum of the scores at followup.

    At Baseline and 3-4 months Follow-up

  • Change in Sexual Health Beliefs From Baseline to Follow-up

    The SHEPS Attitudes section comprises 27 items. Participants rate their level of agreement (1=strongly agree; 5=strongly disagree), with 13 items being reverse coded. Because there are 27 items in this section, participants can have a minimum total score of 27 and a maximum total score of 135. Low scores correspond to "liberal" views and high scores correspond to "conservative" views. A single value was calculated for the intervention arm and waitlist control from difference scores (calculated as follow-up minus baseline scores).

    At Baseline and 3-4 months Follow-up

Study Arms (2)

Intervention Arm

EXPERIMENTAL

A four-day comprehensive sexual health curriculum tailored for Africa.

Behavioral: Comprehensive sexual health curriculum

Waitlist control

NO INTERVENTION

Participants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial.

Interventions

This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing knowledge, attitude change and skill development. At the end of the intervention as compared with waitlist controls. The intervention was a 4-day, Afrocentric, comprehensive sexual health curriculum. Tanzanian faculty wrote the curriculum in English and Kiswahili to address the most common sexual health challenges clinicians experience in Tanzania. The 4-day curriculum covers sexual health across the lifespan, LGBT and sexual violence, clinical skills training, ethics and policy writing, and community resources and cultural considerations.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

  • current student at MUHAS in midwifery, nursing, or medicine.
  • rd or 4th year for medical students or 2nd or 3rd year for nursing and midwifery students.
  • able to attend the full 4-day training during the first week of student vacation.
  • fluent in English (the language of instruction at MUHAS) and Kiswahili (the lingua franca in Tanzania).
  • willing to volunteer and complete all evaluation procedures.

You may not qualify if:

  • students who will not be able to attend MUHAS all days of the seminar or be on the MUHAS campus for the follow-up dates.
  • students who express severe reservations about attending (e.g., due to religious objections).
  • Students who express fear of violence due to attending (e.g., from a spouse or relative).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Muhimbili University of Health and Allied Sciences (MUHAS)

Dar es Salaam, Tanzania

Location

Related Publications (12)

  • 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
  • Rosser BRS, Mgopa L, Leshabari S, Ross MW, Lukumay GG, Massawe A, Mkonyi E, Mohammed I, Mushy S, Mwakawanga D, Trent M, Wadley J. Legal and Ethical Considerations in the Delivery of Sexual Health Care in Tanzania. Afr J Health Nurs Midwifery. 2020;3(7):84-102. Epub 2020 Dec 27.

    PMID: 34723251BACKGROUND
  • Mgopa LR, Rosser BRS, Ross MW, Lukumay GG, Mohammed I, Massae AF, Leshabari S, Mkonyi E, Mushy SE, Mwakawanga DL, Trent M, Wadley J, Bonilla ZE. Cultural and clinical challenges in sexual health care provision to men who have sex with men in Tanzania: a qualitative study of health professionals' experiences and health students' perspectives. BMC Public Health. 2021 Apr 7;21(1):676. doi: 10.1186/s12889-021-10696-x.

    PMID: 33827508BACKGROUND
  • Mgopa LR, Ross MW, Lukumay GG, Mushy SE, Mkony E, Massae AF, Mwakawanga DL, Leshabari S, Mohamed I, Trent M, Wadley J, Bonilla ZE, Rosser BRS. Perceptions of Sexual Healthcare Provision in Tanzania: a Key Informant Qualitative Study. Sex Res Social Policy. 2022 Sep;19(3):849-859. doi: 10.1007/s13178-021-00607-5. Epub 2021 Jul 3.

    PMID: 36172532BACKGROUND
  • Mgopa LR, Rosser BRS, Ross MW, Mohammed I, Lukumay GG, Massae AF, Mushy SE, Mwakawanga DL, Mkonyi E, Trent M, Bonilla ZE, Wadley J, Leshabari S. Clinical Care of Victims of Interpersonal Violence and Rape in Tanzania: A Qualitative Investigation. Int J Womens Health. 2021 Jul 24;13:727-741. doi: 10.2147/IJWH.S301804. eCollection 2021.

    PMID: 34335058BACKGROUND
  • Mushy SE, Rosser BRS, Ross MW, Lukumay GG, Mgopa LR, Bonilla Z, Massae AF, Mkonyi E, Mwakawanga DL, Mohammed I, Trent M, Wadley J, Leshabari S. The Management of Masturbation as a Sexual Health Issue in Dar es Salaam, Tanzania: A Qualitative Study of Health Professionals' and Medical Students' Perspectives. J Sex Med. 2021 Oct;18(10):1690-1697. doi: 10.1016/j.jsxm.2021.07.007. Epub 2021 Aug 24.

    PMID: 34452866BACKGROUND
  • Mwakawanga DL, Mkonyi E, Mushy SE, Trent M, Bonilla Z, Massae AF, Lukumay GG, Mgopa LR, Mohammed I, Wadley J, Ross MW, Leshabari S, Rosser BRS. Would you offer contraception to a 14-year-old girl? Perspectives of health students and professionals in Dar es Salaam, Tanzania. Reprod Health. 2021 Dec 11;18(1):245. doi: 10.1186/s12978-021-01294-6.

    PMID: 34895267BACKGROUND
  • Mkonyi E, Mwakawanga DL, Rosser BRS, Bonilla ZE, Lukumay GG, Mohammed I, Mushy SE, Mgopa LR, Ross MW, Massae AF, Trent M, Wadley J. The management of childhood sexual abuse by midwifery, nursing and medical providers in Tanzania. Child Abuse Negl. 2021 Nov;121:105268. doi: 10.1016/j.chiabu.2021.105268. Epub 2021 Aug 17.

    PMID: 34416472BACKGROUND
  • Lukumay GG, Mgopa LR, Mushy SE, Rosser BRS, Massae AF, Mkonyi E, Mohammed I, Mwakawanga DL, Trent M, Wadley J, Ross MW, Bonilla Z, Leshabari S. Community myths and misconceptions about sexual health in Tanzania: Stakeholders' views from a qualitative study in Dar es Salaam Tanzania. PLoS One. 2023 Feb 10;18(2):e0264706. doi: 10.1371/journal.pone.0264706. eCollection 2023.

    PMID: 36763616BACKGROUND
  • Rosser BRS, Mkoka DA, Rohloff CT, Mgopa LR, Ross MW, Lukumay GG, Mohammed I, Massae AF, Mkonyi E, Mushy SE, Mwakawanga DL, Kohli N, Trent ME, Wadley J, Bonilla ZE. Tailoring a sexual health curriculum to the sexual health challenges seen by midwifery, nursing and medical providers and students in Tanzania. Afr J Prim Health Care Fam Med. 2022 May 31;14(1):e1-e9. doi: 10.4102/phcfm.v14i1.3434.

    PMID: 35695444BACKGROUND
  • Rosser BRS, Kohli N, Bates AJ, Talley KMC, Wright MM, Polter EJ, Wheldon CW, Haggart R, Dickstein DR, Ross MW, Zhang Z, West W, Konety BR. Does sexual rehabilitation work for gay and bisexual prostate cancer patients? Acceptability, feasibility, and efficacy results from the Restore-2 randomized controlled trial. J Cancer Surviv. 2024 Sep 12. doi: 10.1007/s11764-024-01672-6. Online ahead of print.

  • Mushy SE, Mkoka DA, Lukumay GG, Massae AF, Rohloff CT, Mgopa LR, Mwakawanga DL, Kohli N, Ross MW, Mkonyi E, Trent M, Athumani K, Kulasingam S, Rosser BRS. The need for and acceptability of a cancer training course for medical and nursing students in Tanzania: a convergent mixed methods study. BMC Med Educ. 2024 Jun 3;24(1):614. doi: 10.1186/s12909-024-05497-w.

MeSH Terms

Conditions

Behavior

Results Point of Contact

Title
Gudrun Kilian
Organization
University of Minnesota

Study Officials

  • B.R Simon Rosser, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A randomized, controlled, single blinded trial, stratified by health profession, of the intervention vs waitlist control.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Development and testing of a sexual health curriculum for Midwifery, Nursing and Medical Students.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

April 22, 2019

Study Start

May 1, 2021

Primary Completion

September 7, 2021

Study Completion

September 20, 2022

Last Updated

August 7, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Only group data will be analyzed.

Locations