Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti.
AIDS Educ Prev
; 10(1): 46-62, 1998 Feb.
Article
en En
| MEDLINE
| ID: mdl-9505098
ABSTRACT
PIP: Cultural feasibility studies use ethnographic methods to explore ethical, behavioral, and social issues inherent in the design of proposed clinical trials. This approach was applied in advance of clinical trials aimed at reducing maternal-infant HIV transmission in Cite Soleil, Haiti. The first focused on conditions that would be necessary to conduct a trial of breast feeding versus exclusive bottle feeding by HIV-positive mothers; the second investigated the feasibility of a double-blind trial of administration of a high- titer antibody preparation--HIV immune globulin (HIVIG)--to infants of seropositive mothers shortly after birth. Study methods included focus group discussions with mothers and in-depth interviews with key informants about AIDS-related beliefs, acceptability of trial participation, risks to subjects, and community repercussions. Concerns identified included the potential negative effect on breast feeding promotion efforts in Haiti, the scarcity of economic means to sustain safe bottle feeding, the risk of being labeled HIV-positive by virtue of study participation, the potential for the HIVIG trial to reinforce the misconception that a vaccine effective against AIDS exists, and problems explaining the concept of a double-blind study and accepting random assignment to treatment and control groups. As a result of these studies, it was decided to conduct the infant feeding study in a community with higher rates of exclusive bottle feeding and lower infant mortality than exist in Cite Soleil. The HIVIG trial could be conducted, but only after extensive community education to ensure informed consent. An objective assessment of subject comprehension was developed for this purpose.
Palabras clave
Biomedical and Behavioral Research; Empirical Approach; Acquired Immunodeficiency Syndrome--prevention and control; Age Factors; Americas; Antibodies; Biology; Bottle Feeding; Breast Feeding; Caribbean; Culture; Delivery Of Health Care; Demographic Factors; Developing Countries; Diseases; Ethics; Haiti; Health; Health Services; Hiv Infections--prevention and control; Hiv Infections--transmission; Immunity; Immunization; Immunologic Factors; Infant; Infant Nutrition; Informed Consent; Latin America; North America; Nutrition; Physiology; Population; Population Characteristics; Primary Health Care; Research Activities; Research Methodology; Research Report; Vertical Transmission; Viral Diseases; Youth
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Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Complicaciones Infecciosas del Embarazo
/
Infecciones por VIH
/
Ensayos Clínicos como Asunto
/
Transmisión Vertical de Enfermedad Infecciosa
/
Poblaciones Vulnerables
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Qualitative_research
/
Risk_factors_studies
Límite:
Child, preschool
/
Female
/
Humans
/
Infant
/
Newborn
/
Pregnancy
País como asunto:
Caribe
/
Haiti
Idioma:
En
Año:
1998
Tipo del documento:
Article