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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03923582
Other study ID # STUDY00006904
Secondary ID R01HD092655
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date September 20, 2022

Study information

Verified date May 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 412
Est. completion date September 20, 2022
Est. primary completion date September 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. current student at MUHAS in midwifery, nursing, or medicine. 2. 3rd or 4th year for medical students or 2nd or 3rd year for nursing and midwifery students. 3. able to attend the full 4-day training during the first week of student vacation. 4. fluent in English (the language of instruction at MUHAS) and Kiswahili (the lingua franca in Tanzania). 5. willing to volunteer and complete all evaluation procedures. Exclusion Criteria: 1. 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. 2. students who express severe reservations about attending (e.g., due to religious objections). 3. Students who express fear of violence due to attending (e.g., from a spouse or relative).

Study Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice
  • Training

Intervention

Behavioral:
Comprehensive sexual health curriculum
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.

Locations

Country Name City State
Tanzania Muhimbili University of Health and Allied Sciences (MUHAS) Dar Es Salaam
United States University of Minnesota Minneapolis Minnesota

Sponsors (4)

Lead Sponsor Collaborator
University of Minnesota Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Johns Hopkins University, Muhimbili University of Health and Allied Sciences

Countries where clinical trial is conducted

United States,  Tanzania, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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