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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD092655 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
| Johns Hopkins University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | A four-day comprehensive sexual health curriculum tailored for Africa. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive sexual health curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B.R Simon Rosser, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Muhimbili University of Health and Allied Sciences (MUHAS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29579491 | Background | 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. | |
| 34723251 | Background | 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. |
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Only group data will be analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | A four-day comprehensive sexual health curriculum tailored for Africa. 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. |
| FG001 | Waitlist Control | Participants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | A four-day comprehensive sexual health curriculum tailored for Africa. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | At Baseline and 3-4 months Follow-up |
|
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adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | A four-day comprehensive sexual health curriculum tailored for Africa. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gudrun Kilian | University of Minnesota | 612-624-0358 | kilian@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2021 | Mar 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2023 | Mar 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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Development and testing of a sexual health curriculum for Midwifery, Nursing and Medical Students.
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A randomized, controlled, single blinded trial, stratified by health profession, of the intervention vs waitlist control.
|
| 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 |
| Dar es Salaam |
| Tanzania |
| 33827508 | Background | 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. |
| 36172532 | Background | 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. |
| 34335058 | Background | 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. |
| 34452866 | Background | 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. |
| 34895267 | Background | 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. |
| 34416472 | Background | 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. |
| 36763616 | Background | 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. |
| 35695444 | Background | 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. |
| 39266938 | Derived | 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. |
| 38831409 | Derived | 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. |
| BG001 | Waitlist Control | Participants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sexual Health Knowledge | Mean | Standard Deviation | units on a scale |
|
| Sexual Health Knowledge: Confidence in Ability to Discuss | Mean | Standard Deviation | units on a scale |
|
| Sexual Health Attitudes: Confidence in Having Knowledge | Mean | Standard Deviation | units on a scale |
|
| Sexual Counseling Skills: Interpersonal Communications | Mean | Standard Deviation | units on a scale |
|
| Sexual Counseling Skills: Medical History Taking | Mean | Standard Deviation | units on a scale |
|
| Sexual Health Belief | Mean | Standard Deviation | units on a scale |
|
A four-day comprehensive sexual health curriculum tailored for Africa.
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.
| OG001 | Waitlist Control | Participants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial. |
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). | Posted | Mean | Standard Deviation | score on a scale | At Baseline and 3-4 months Follow-up |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Waitlist Control | Participants in this arm completed a follow-up survey and were scheduled to receive the intervention after the end of the trial. | 0 | 0 | 0 | 0 | 0 | 0 |
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