Children and HIV

Cohort retention of infants and children born to HIV-infected women

Relevance for Title IV Providers: RWCA sites play an important role in helping their clients to access clinical research trials.

Study Question(s): What factors may encourage inner-city families affected by pediatric HIV to stay in long-term studies?

Study Participants: 298 participants were recruited from a 5-year prospective cohort study, the Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2 Study). Group I (n=205) contained infants and children who were HIV-infected through mother-to-child HIV transmission and were older than 28 days at baseline. Group II (n=93) included HIV-positive mothers that agreed to enroll their infants before the infant's HIV status was known. The children were primarily African-American (49%) and Hispanic (33%); 51% were male.

Study Methods: Infants in Group I were seen every 6 months and those in Group II were seen every 3 months. Nurse coordinators and nursing staff conducted respiratory and cardiac examinations, laboratory tests, chest radiographs, electrocardiography, 24-hour Holter monitor assessments, pulmonary function testing, and echocardiography. At the end of the study, caregivers described the factors that encouraged them to stay in the study.

Study Findings: Nearly 4/5 of the HIV-infected children enrolled completed the study. Incentives the caregivers considered important included phone calls with nurse coordinators, nurse coordinators accompanying the caregiver and child during visits, phone reminders for appointments, help with scheduling, meals and transportation, access to health care, and relationships with staff. Study staff aggressively tracked families who missed visits with repeated telephone calls. This became less necessary as the caregivers and study staff established closer relationships.

Limitations:

	Demographic data were not collected from caregivers at baseline.
	Exit interviews were administered by the nurse coordinators rather than by a third party unknown to the caregivers.
	The nursing interventions were not completely standardized and varied between sites.

Lessons Learned: Although study visits were often long and uncomfortable, after five years, 80% of participants were still involved in the study. The high follow-up rate is attributed, in part, to nurses' efforts to reduce the study's burden on the families, provide incentives to increase access to the health care system, and establish personal relationships with families.

Implications for Title IV Providers: Many families living with HIV infection also suffer the effects of poverty and a host of other problems associated with inner-city life. Title IV providers support families to facilitate regular access to health care. Retaining families in research studies on rigorous follow-up schedules is even more challenging for Title IV providers. This study identified some of the strategies that will assist Title IV providers in supporting participation in clinical research trials.

Source: Geromanos K, Sunkle SN, Mauer MB, Carp D, Ancker J, Zhang W, Easley KA, Schluchter MD, Kozinetz CA, Mellins RB. Successful techniques for retaining a cohort of infants and children born to HIV-infected women: the prospective P2C2 HIV study. J Assoc Nurses AIDS Care. 2004 Jul-Aug;15(4):48-57.