- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07587281
Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Nairobi, Kenya
- Amref Health Africa in Kenya
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Adolescent participants
Inclusion criteria:
- age 15-19
- residing in one of the informal settlements participating in the study
- not planning to relocate for 18 months
- not currently married or living as married
- comprehension of informed consent
- willing to provide assent/consent
Exclusion criteria:
- Age 14 and younger
- Age 20 and older
- Married/living as married
- Planning to relocate within 18 months
- Not residing in one of the informal settlements participating in the study
- Unable to comprehend informed consent
- Unwilling to provide assent/consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: AskDoki plus Digital Champions
Intervention communities receive access to the AskDoki WhatsApp chatbot delivering comprehensive sexuality education, with support from trained youth peer leaders ("Digital Champions") who facilitate adolescent engagement with the program.
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A chatbot designed to provide comprehensive sexuality education (named "AskDoki") to adolescents is deployed in a community targeted to receive the intervention along with peer facilitators.
The facilitators are young adults (named "Digital Champions") who are trained to promote and facilitate access and use among adolescents of a chatbot.
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Aucune intervention: No access to AskDoki or Digital Champions
Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-efficacy to abstain
Délai: Baseline and 6 months post-intervention
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Change in respondents' confidence in their ability to abstain from sex.
Example item: "I can refuse sex when I don't feel like having sex."
Five summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Sexual self-efficacy
Délai: Baseline and 6 months post-intervention
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Change in respondents' confidence to negotiate and use condoms.
Example item: "I can negotiate condom use with a potential partner".
Eight summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Perceived advantages of delaying sex
Délai: Baseline and 6 months post-intervention
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Change in respondents' perceptions about the advantages of delaying sex.
Example item: "Waiting until I am older before I have sex will… Help me achieve my life's goals."
Five summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Perceived disadvantages of delaying sex
Délai: Baseline and 6 months post-intervention
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Change in respondents' perceptions about the disadvantages of delaying sex.
Example item: "Waiting until I am older before I have sex will… Make me look old-fashioned."
Four summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Attitudes towards condoms
Délai: Baseline and 6 months post-intervention
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Change in respondents' perceptions about condom use.
Example item: "It is OK to use condoms."
Five summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Perceived norms of delaying sex
Délai: Baseline and 6 months post-intervention
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Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning delaying sex.
Example item: "Most of my friends think that I should wait until I am older before I have sex."
Four summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Subjective norms about condoms
Délai: Baseline and 6 months post-intervention
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Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning condoms.
Example item: "My friends think that I should carry a condom."
Four summed items.
Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).
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Baseline and 6 months post-intervention
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Intention to abstain from sex
Délai: Baseline and 6 months post-intervention
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Change in respondents' intention to have sex within next month, 6 months, a year. Example item: "I intend to have sex within the next month." Three items summed and averaged. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree). Responses are inversely coded to reflect intention to abstain from sex. |
Baseline and 6 months post-intervention
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Intentions to use condoms
Délai: Baseline and 6 months post-intervention
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Change in respondents' intention to use a condom during sexual intercourse.
Single item: "I plan to use a condom when I have sexual intercourse."
Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).
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Baseline and 6 months post-intervention
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Sexual Behavior
Délai: Baseline and 6 months post-intervention
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Change in respondents' sexual behavior.
Example item: "Have you had vaginal sex with anyone in the past 6 months?"
(yes/no).
Three items to assess any sexual activity (i.e., anal, oral, and vaginal sex).
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Baseline and 6 months post-intervention
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Frequency of sexual activity
Délai: Baseline and 6 months post-intervention
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Change in how often respondents had sex in past month.
Single item: "In the past month, how frequently did you have sex?"
Five response options from "Zero times" to "More than four times a week."
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Baseline and 6 months post-intervention
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Condom use at last sex
Délai: Baseline and 6 months post-intervention
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Condom used at last sex reported in survey.
Single item: "Did you or your partner use a condom the last time your had sex?" (yes/no).
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Baseline and 6 months post-intervention
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Condom use consistency
Délai: Baseline and 6 months post-intervention
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Condom use frequency reported in survey.
Single item: "In the past month, how frequently did you use a condom when having sex?" Five response options ("Never, none of the time" to "Always, every time").
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Baseline and 6 months post-intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge about sexual and reproductive health
Délai: Baseline and 6 months post-intervention
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Measures change in knowledge about sexually transmitted infections (STIs), sexual behavior, and pregnancy.
Example item: "Can a person who looks strong and healthy be HIV positive?"
(yes/no) Items will be summed and averaged.
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Baseline and 6 months post-intervention
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Self-reported STI symptoms
Délai: Baseline and 6 months post-intervention
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Respondents' self-reported STI symptoms.
Example item: "Do you currently have any of the following symptoms?... Sore or lesions in your genital area or anus" (yes/no).
Six items will be used to derive prevalence and distribution of STI symptoms.
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Baseline and 6 months post-intervention
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Self-reported history of adolescent pregnancies
Délai: Baseline and 6 months post-intervention
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Respondents' self-reported history of pregnancy and impregnating someone.
Example item: "Are you or your partner currently pregnant?""
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Baseline and 6 months post-intervention
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Intention to test and treat STIs
Délai: Baseline and 6 months post-intervention
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Two survey items assessing intentions to test and treat STIs.
Example item: "I plan to visit a clinic to test for STIs if I have symptoms."
Two summed items.
Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).
Items were newly created for this study.
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Baseline and 6 months post-intervention
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Intention to use SRH services
Délai: Baseline and 6 months post-intervention
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Increase in intention to use SRH services.
Single item: "I plan to visit a clinic for family planning services."
Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).
Item was newly created for this study.
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Baseline and 6 months post-intervention
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Retention of Digital Champions
Délai: Start-up of intervention through six-month intervention period
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Percent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.
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Start-up of intervention through six-month intervention period
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
Délai: Immediately post-intervention
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Average of 6 items about acceptability on post intervention survey.
Example item: "Overall, how acceptable did you find the Digital Champions?"
Response options are on a 5-point Likert scale.
Items were adapted from a questionnaire based on the Theoretical Framework of Acceptability.
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Immediately post-intervention
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Cost per adolescent served.
Délai: Start-up of intervention through six-month intervention period
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Cost effectiveness is computed as the cost of intervention divided by the number of adolescents served.
Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.
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Start-up of intervention through six-month intervention period
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Cost per adolescent who makes progress on outcome measures
Délai: Start-up of intervention through six-month intervention period
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Cost per adolescent who makes progress on outcome measures.
Cost effectiveness is computed as the cost of intervention divided by the number of positive outcomes.
The cost effectiveness ratios we compute will depend on what outcomes increase significantly relative to the comparison group.
Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.
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Start-up of intervention through six-month intervention period
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1200
- R21TW012623 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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