- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04805112
Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will recruit HIV-negative adolescents girls (AG) aged 15-19 years in Siaya County, western Kenya. The study will evaluate the impact of the provision of oral HIV self-testing on uptake of testing among partners of adolescent girls. We will randomize about 300 sexually active AG to either an intervention group that receives multiple oral self-test kits that they can choose to offer to their sexual partner(s) or to a control group that will be given multiple referral coupons that their partners can use for HIV testing at pre-selected HIV testing services (HTS) sites. We will collect data on whether the kits were offered, to whom they were offered, if they were accepted, if they were used and with what results, if known, and if the partners who obtained HIV-positive results sought confirmatory testing. We will also conduct in-depth interviews with a sub-set adolescents to explore their experiences in offering HIV self-testing to their male partners.
This study has 4 specific aims: i) determine whether adolescent girls can safely offer oral HIV self-tests to their partners; ii) assess whether oral self-testing improves uptake of HIV testing among partners of adolescent girls; iii) document adverse events associated with offering oral self-testing to sexual partners of adolescent girls; and iv) qualitatively explore the experiences of adolescent girls when offering self-test kits to their partners.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kisumu, Kenia
- Impact Research & Development Organization
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female
- Aged 15-19 years
- HIV-negative (willing to self-test onsite in the presence of the Research Assistant who is also a trained HIV counselor)
- Has at least one current sexual partner she expects to meet at least twice in the next 3 months (not necessarily to have sex); this will provide opportunity for the participant to suggest/offer testing.
- Resides in Siaya County and does not intend to relocate within 6 months from enrollment, to allow follow up to be completed and to conduct IDI with those selected.
- Willing to be randomized into the partner self-testing or HTS referral groups.
- Reporting no incident of sexual, physical, emotional, or economic abuse in the last 12 months from the partner she intends to offer (Appendix 4) or refer for testing (Appendix 3) in the next 3 months and does not believe the partner will abuse her if she offers the self-test kits or HTS referral coupon.
- Has a male partner who has not tested for 6 months or whose HIV status is unknown to her.
- Agrees to give consent to participate in the study.
Exclusion Criteria:
- Male
- HIV-positive
- Not willing to self-test onsite under in the presence of the Research Assistant
- Aged <15 years or >19 years
- Does not have a current sexual partner or does not expect to meet the partner at least twice in the next 3 months
- Does not reside in Siaya County or intends to relocate within the next 6 months
- Not interested in obtaining HIV self-tests or HTS referral coupon for purposes of suggesting testing to their sexual partners
- Reporting an incidence of sexual, physical, emotional or economic abuse in the last 12 months from the partner she would have offered self-test kit or referred for testing, or believes the partner may subject her to sexual, physical, emotional, or economic abuse if she offered them self-test kit or HTS coupon.
- Has a male partner who tested within the last 6 months.
- Does not give consent to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Provision of multiple self-tests
Participants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s).
The participant will be instructed to encourage their partner to test himself alone [partner testing] or with the participant [couple testing]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing.
All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information
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Participants will be given multiple Oraquick Advance HIV-1/2 test kits to distribute to their sexual partners for partner testing or couple testing.
Phone interviews will be conducted with the participants to assess whether they provided a HIV self-test to their partner, if the test was used, how it was used (partner testing or couple testing), if the partner disclosed his results, the partner's reaction to the results, and if the partner went for confirmatory testing
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Sin intervención: Referral vouchers for clinic testing
Participants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites.
The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone [partner testing] or together with the participant [couple testing].
The coupon will also have information on testing and a list of facilities where he can go for HTS.
All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
uptake of partner HIV testing
Periodo de tiempo: 3 months
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proportion of partners that complete HIV testing
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3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Introduce testing
Periodo de tiempo: 3 months
|
proportion of participants who introduce testing to their partners
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3 months
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Partner accept testing
Periodo de tiempo: 3 months
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proportion of partners who were offered HIVST or referral coupon and accepted
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3 months
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Partner testing
Periodo de tiempo: 3 months
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proportion of participants who report their partner tested alone
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3 months
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Couples testing
Periodo de tiempo: 3 months
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proportion of participants who report testing with their partner
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3 months
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Positive partner
Periodo de tiempo: 3 months
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proportion of participants who report their partner test result was positive
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3 months
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linked to care
Periodo de tiempo: 3 months
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Proportion of participants who report their partners was linked to care
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3 months
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Intimate partner violence
Periodo de tiempo: 3 months
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proportion of participants in each study group who report intimate partner violence related to HIV testing
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3 months
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Confirmatory testing for positive HIV self-test
Periodo de tiempo: 3 months
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proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kawango Agot, PhD, Impact Organization & Research Development
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- 848410
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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