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Formazione per gli operatori sanitari 2: Obiettivo 1 (THP-2)

9 ottobre 2026 aggiornato da: University of Minnesota

Valutazione degli effetti della formazione sulla salute riproduttiva sul comportamento del fornitore

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

Panoramica dello studio

Descrizione dettagliata

All enrollees will be health students at MUHAS recruited through announcements in class, flyers on student noticeboards, and email. Students who are interested in learning more about the study can do so by asking questions of the recruiting faculty member, by going to, telephoning, or emailing the study office (at MUHAS). Students can also visit the study website. In addition, all students who contact the office will be given a copy of a flyer advertising the study and a copy of the consent documents to preview prior to participation. Students contacting the office by email will be sent electronic versions of the same documents.

Participants in Aim 1 are informed to schedule an appointment (in the month prior to the seminar) to complete a pre-evaluation. At the study site, participants complete pen and paper surveys, and are videotaped interviewing two standardized patients. Next, participants are randomized to either the intervention or waitlist control condition. Participants in the intervention will attend the 4-day sexual health seminar and complete a short post-test. In addition, at 6- and 12-month follow-up after the pre-test, participants in both arms complete surveys and two videotaped interviews (at each follow-up) and a final survey at 24-month follow-up. At the end of the study, participants assigned to the control condition can attend the seminar.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

312

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Dar es Salaam, Tanzania
        • Muhimbili University of Health and Allied Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • A health student studying at MUHAS and verified by being registered as a pre-final year midwifery, nursing or medical student (or its equivalent).
  • "Pre-final" year is defined as a student who is just about to enter year 3 of nursing, or year 4 of midwifery or medicine.
  • Living or studying in Tanzania
  • Experienced, operationalized as having worked at least 100 hours as a health worker in a clinic, hospital or community setting so students can discuss what happens in the clinical setting
  • Able to speak English and Kiswahili.

Exclusion Criteria:

  • Students who will not be able to attend all days of the seminar at their health institution or be on their campus for the follow-up.
  • Students who express any reservations about attending (e.g., due to religious objections)
  • Students who express a fear of violence due to attending (e.g., from a spouse or relative).
  • Students who attended the sexual health seminar (e.g., during THP-1 or at another site). This is to prevent a student participating more than once.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Comprehensive Sexual Health Curriculum

Participants received a four-day comprehensive sexual health curriculum tailored for Africa.

This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing the effects on sexual health knowledge, attitudes, and sexual history and counseling skills at medium (6-) and long-term (12 and 24 months) follow-up. 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, lesbian, gay, bisexual, and transgender (LGBT) and sexual violence, clinical skills training, ethics, and community resources and cultural considerations.

Nessun intervento: Waitlist Control

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Sexual Health Knowledge Score
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Attitudes: Confidence in Ability to Discuss
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Attitudes: Confidence in Having Knowledge
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Counseling Skills: Interpersonal Communications
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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. The investigators 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Counseling Skills: Medical History Taking
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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. The investigators 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
Change in Sexual Health Beliefs
Lasso di tempo: Baseline, 6-month follow-up, 12-month follow-up, and 24-month 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.

Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: B.R. Simon Rosser, PhD, University of Minnesota

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 giugno 2024

Completamento primario (Effettivo)

1 ottobre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

20 maggio 2024

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2024

Primo Inserito (Effettivo)

24 maggio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R01HD092655 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Only group data will be analyzed.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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