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Health Knowledge, Attitudes, PracticeTHPNCT03923582

Training for Health Professionals In Tanzania

A study testing Comprehensive sexual health curriculum in people with Health Knowledge, Attitudes, Practice and Training, run by University of Minnesota at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Comprehensive sexual health curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
2 sitesin 2 countries
Study dates
1 May 2021to 20 Sep 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 MUHAS in midwifery, nursing, or medicine.
  • 3rd 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

Tanzania1 site
  • Muhimbili University of Health and Allied Sciences (MUHAS)

    Dar es Salaam

Other trials in Tanzania

About this study

Official title: Training for Health Professionals in Tanzania

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.

Read the detailed description

There were 563 students recruited for the study that met the eligibility requirement. A total of 412 students gave consent and were randomized into intervention and control groups. At baseline, participants took a survey covering demographic information, educational background, sexual health knowledge, and attitudes toward sexual health topics. After completing the survey, participants participated in two standardized patient interviews involving actors role playing sexual health-related patient scenarios.

Those who were in the intervention arm participated in a 4-day sexual health curriculum followed by a post-test survey measuring sexual health knowledge, attitudes, and evaluation of sexual health training.

Three to four months later, intervention and waitlist control participants completed a follow-up survey assessing sexual health knowledge and attitudes toward sexual health topics and standardized patients scenarios.

Multiple linear regression was used to assess the overall effectiveness of the sexual health curriculum on the attitudes, knowledge, and skills of health professionals after it has been implemented.

Being tested
Comprehensive sexual health curriculum
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive sexual health curriculumBehavioural

    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.

Study groups in NCT03923582
Study groupRoleWhat they receive
Intervention ArmExperimentalA four-day comprehensive sexual health curriculum tailored for Africa.
Receives: Behavioral: Comprehensive sexual health curriculum
Waitlist controlNo interventionParticipants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At Baseline and 3-4 months Follow-up

  2. 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).

    Measured: At Baseline and 3-4 months Follow-up

  3. 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).

    Measured: At Baseline and 3-4 months Follow-up

  4. 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.

    Measured: At Baseline and 3-4 months Follow-up

  5. 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.

    Measured: At Baseline and 3-4 months Follow-up

  6. 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).

    Measured: At Baseline and 3-4 months Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2019
  2. Study start1 May 2021
  3. Primary completion7 Sep 2021
  4. Study completion20 Sep 2022

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Development and testing of a sexual health curriculum for Midwifery, Nursing and Medical Students.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03923582
Sponsor's protocol ID
STUDY00006904
Other IDs
R01HD092655
Acronym
THP
Status last verified
Jul 2024
First submitted
1 Aug 2018
Last updated
7 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only group data will be analyzed.

Publications

  • 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.

    PubMed 29579491
  • 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.

    PubMed 34723251
  • 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.

    PubMed 33827508
  • 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.

    PubMed 36172532
  • 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.

    PubMed 34335058
  • 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.

    PubMed 34452866
  • 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.

    PubMed 34895267
  • 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.

    PubMed 34416472
  • 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.

    PubMed 36763616
  • 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.

    PubMed 35695444
  • 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. 2026 Apr;20(2):566-580. doi: 10.1007/s11764-024-01672-6. Epub 2024 Sep 12.

    PubMed 39266938
  • 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.

    PubMed 38831409

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive sexual health curriculum in people with Health Knowledge, Attitudes, Practice and Training, run by University of Minnesota at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sexual Health Knowledge Score From Baseline to Follow-up (time frame: At Baseline and 3-4 months Follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03923582, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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