- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00771537
HIV Testing & Womens Attitudes on HIV Vaccine Trials
28 de junio de 2013 actualizado por: Gregory Zimet, Indiana University
The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial.
Adult African-American, non-Latina White, and Latina women will be recruited.
Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger opposition to testing, then refutes the opposition.
Women will be offered HIV testing, then re-randomized to a similar set of 4 messages related to HIV vaccine trials.
There will therefore be 16 groups in total (4 X 4).
Descripción general del estudio
Descripción detallada
This 5-year proposal responds to PAS-03-168, "Enrolling Women and Minorities in HIV/AIDS Research Trials."
This study seeks to evaluate persuasive message interventions to increase HIV testing rates and improve acceptability of participation in a phase 3 HIV vaccine clinical trial among African-American, Latina, and White women.
We plan to evaluate 1-sided messages, which mention only the benefits of an action, versus 2-sided messages, which mention negative aspects of the action, followed by positive counterarguments.
The Health Belief Model, Inoculation and Attribution Theories will guide the research.
Participants will be women attending urban community health clinics in Indianapolis, IN. Specific Aim 1 is to identify obstacles to HIV testing and to participation in a HIV vaccine clinical trial.
This aim will be accomplished in years 1 and 2 through individual semi-structured interviews.
We will analyze data via thematic content analysis and will use interview findings to assist in the development of measures and interventions employed in the intervention phase (years 3-5).
Specific Aim 2 is to evaluate the effects of 2-sided versus 1-sided persuasive messages on rates of acceptance of rapid HIV testing.
Demographic, behavioral, and attitudinal measures will be administered via audio computer-assisted self-interview (A-CASI).
Participants will be randomized to the intervention groups via A-CASI as well.
The outcome will be acceptance/rejection of free rapid HIV testing.
This Aim will be evaluated via binary logistic regression.
Specific Aim 3 is to evaluate the effects of 2-sided versus 1-sided messages on willingness to participate in phase 3 clinical trials for a preventive HIV vaccine.
Participants will complete this 2nd A-CASI survey and will again be randomized to intervention groups.
The outcome will be a scale measuring acceptability of clinical trial participation.
This Aim will be evaluated via one-way Analysis of Variance.
This study is relevant to public health in that the results may help us to understand how to improve enrollment of women and minorities into preventive HIV vaccine clinical trials and how to encourage women and minorities to get tested for HIV.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2031
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Medical Group Clinics
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Female
- 18 years of age or older
- Able to understand English or Spanish
- Able to give informed consent
Exclusion Criteria:
- Not female
- Under 18 years of age
- Not able to understand English and Spanish
- Unable to give informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Arm 1. Control PLUS Control
|
|
Experimental: Arm 2. Control PLUS 1-Sided
No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 3. Control PLUS 2-Sided Trivial
No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 4. Control PLUS 2-Sided Major
No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 5. 1-Sided PLUS Control
1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 6. 1-Sided PLUS 1-Sided
1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 7. 1-Sided PLUS 2-Sided Trivial
1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Aim 8. 1-Sided PLUS 2-Sided Major
1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 9. 2-Sided Trivial PLUS Control
2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 10. 2-Sided Trivial PLUS 1-Sided
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 12. 2-Sided Trivial PLUS 2-Sided Major
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 13. 2-Sided Major PLUS Control
2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 14. 2-Sided Major PLUS 1-Sided
2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 15. 2-Sided Major PLUS 2-Sided Trivial
2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
|
Experimental: Arm 16. 2-Sided Major PLUS 2-Sided Major
2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
|
There are 16 pairs of messages varying in sidedness.
Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation.
Arm 2 is control + a 1-sided message.
Arm 3 is control + a trivial 2-sided message.
Arm 4 is control + a major 2-sided message.
Arm 5 is a 1-sided message + a control.
Arm 6 is a 1-sided message + a 1-sided message.
Arm 7 is a 1-sided message + a trivial 2-sided message.
Arm 8 is a 1-sided message + a major2-sided message.
Arm 9 is a trivial 2-sided message + a control.
Arm 10 is a trivial 2-sided message + a 1-sided message.
Arm 11 is a trivial 2-sided message + a trivial 2-sided message.
Arm 12 is a trivial 2-sided message + a major 2-sided message.
Arm 13 is a major 2-sided message + a control.
Arm 14 is a major 2-sided message + a 1-sided message.
Arm 15 is a major 2-sided message + a trivial 2-sided message.
Arm 16 is a major 2-sided message + a major2-sided message.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Accepted Rapid HIV Testing.
Periodo de tiempo: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
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Acceptance of rapid HIV testing.
Acceptance was assessed by actual administration of rapid oral HIV test by research staff.
|
During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
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Willingness to Participate in a HIV Vaccine Clinical Trial
Periodo de tiempo: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
|
Willingness to Participate in a HIV Vaccine Clinical Trial.
Assessed via participant self-report with 6 items on Part 2 of the questionnaire.
Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).
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Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Burrage JW, Zimet GD, Cox DS, Cox AD, Mays RM, Fife RS, Fife KH. The Centers for Disease Control and Prevention revised recommendations for HIV testing: reactions of women attending community health clinics. J Assoc Nurses AIDS Care. 2008 Jan-Feb;19(1):66-74. doi: 10.1016/j.jana.2007.11.003.
- Kasting ML, Cox AD, Cox D, Fife KH, Katz BP, Zimet GD. The effects of HIV testing advocacy messages on test acceptance: a randomized clinical trial. BMC Med. 2014 Nov 6;12:204. doi: 10.1186/s12916-014-0204-4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2006
Finalización primaria (Actual)
1 de enero de 2011
Finalización del estudio (Actual)
1 de enero de 2011
Fechas de registro del estudio
Enviado por primera vez
10 de octubre de 2008
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2008
Publicado por primera vez (Estimar)
13 de octubre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de julio de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
28 de junio de 2013
Última verificación
1 de junio de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 0601-09
- R01NR010004 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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