Pediatric Care and Treatment

Protocol Title: Barriers and Facilitators of Early Infant Diagnosis and Treatment (EIDT) Services in Malawi

About this study: This ViiV-funded study, using a qualitative design, aimed to document facilitators and barriers across the early infant diagnosis and treatment cascade.  Study staff conducted semi-structured interviews with caregivers of infants eligible for early infant HIV diagnosis (n=47) and health care workers in five clinics in Malawi in April 2013. Study staff collected data addressing five steps of the EIDT cascade: 1) identification of HIV-exposed infants; 2) infant testing; 3) sample processing and transport; 4) reporting results to caregivers; and 5) ART initiation for HIV-positive infants.

Status: This study has been completed.

Protocol Title: Enhancing uptake of HIV testing and ART for infants of HIV-positive mothers in Tanzania

About this study: Low rates of facility delivery, late postnatal care entry, and missed opportunities for early infant diagnosis and treatment hamper Tanzania’s achievement of prevention of mother-to-child HIV transmission (PMTCT) and maternal, neonatal and child health (MNCH) goals. The goal of this study, funded by the United States Agency for International Development through the Population Council, is to increase the proportion of pregnant women who deliver in a facility, the proportion of HIV-exposed infants (infants born to a HIV-positive mother) who receive nevirapine within 48 hours of delivery, and the proportion of HIV-exposed infants who are tested for HIV using DNA PCR testing within eight weeks of age. Specific objectives are to evaluate the feasibility and effectiveness of several intervention packages: (1) a health intervention alone, which consists of SMS/text message reminders sent to patients to both educate them on HIV and remind them of upcoming necessary appointments; (2) the health intervention plus a transport reimbursement for clinic appointments and facility delivery; or (3) no SMS or transport intervention – only standard care provided. 1,400 women from about 30 PMTCT/ MNCH sites in the Tabora Region of Tanzania will be randomized into the three study arms. A baseline and follow-up questionnaire will be administered, and women who are lost to follow-up at eight weeks postpartum will be actively traced to obtain study endpoints. Pre- and post-intervention, approximately 50 individuals (patients and health providers) will complete qualitative interviews to inform the intervention implementation, and complement the quantitative data on feasibility and effectiveness.

Outcomes from this study will inform decision makers about the effectiveness of the two intervention models (mHealth alone or mHealth + transport reimbursement) on increasing utilization of antenatal care, delivery, and postnatal services for HIV positive women and the general population.

Status: The qualitative analysis is complete. The intervention study is ongoing.

Protocol Title: Towards getting more HIV-positive infants on lifesaving treatment: Assessing turn-around times for early infant diagnosis in Lesotho

About this Study: This Dance Marathon at UCLA-funded study aimed to identify delays in the early infant diagnosis process, from the time a six to eight week old HIV-exposed child is tested for the disease to the point at which results are given to the caregiver and ART is initiated for those infected. Perinatal HIV infection among HIV-exposed infants at six to eight weeks of age and PMTCT-related services received among these infant/mothers was also assessed. The study used a retrospective cohort design; facility records were accessed from 25 sites in all ten districts of Lesotho.

Status: This study has been completed.

Resources Published to Date:

Protocol Title: Exploring Facilitators and Barriers to Participation of HIV-Exposed and HIV-Infected Children in Care and Treatment Services in two Provinces in Mozambique

About this Study: This U.S. Centers for Disease Control and Prevention--funded study aimed to identify barriers and supportive factors associated with identification and enrollment of HIV-positive children into HIV care and treatment services in two regions of Mozambique. Parents, caregivers, health care workers and community leaders participated in interviews and focus group discussions. Facility assessments of services at study sites were also conducted.

Status: This study has been completed.

Resources Published to Date:

Protocol Title: Evaluation of the XPERT® HIV-1 Qual Assay

About this Study: This CEPHEID-funded study was a preliminary performance evaluation of the Xpert HIV-1 Qual Assay for rapid detection of HIV-1 total nucleic acids in DBS from HIV+ and HIV- infants in Lesotho (30 each).

Status: This study has been completed.

Protocol Title: Assessing the Feasibility, Acceptability, and Costs Associated with Very Early Infant Diagnosis at Birth in Lesotho and Rwanda

About this Study: Very early HIV infant diagnosis, followed by the receipt of life-saving treatment for HIV-infected infants, has potential to avert the progressive rise in infant mortality observed within the first months of life in high-prevalence settings. The goal of this study, funded by Population Council through the Project Supporting Operational AIDS Research (Project SOAR), is to determine the feasibility, acceptability, and costs associated with additional birth HIV testing to the routine testing algorithm for infants born to HIV-positive women. This evaluation will leverage existing activities from two USAID-funded prospective observational cohort studies in Lesotho and Rwanda.

Status: Recently launched.