Genomic sequencing in diverse and underserved pediatric populations: Parent perspectives on understanding, uncertainty, psychosocial impact, and personal utility of results.

Purpose: Limited evidence evaluates parents' perceptions of their child's clinical genome-scale sequencing (GS) results, particularly among individuals from medically underserved groups. Five Clinical Sequencing Evidence-Generating Research consortium studies performed GS in children with suspected genetic conditions with high proportions of individuals from underserved groups to address this evidence gap.

Methods: Parents completed surveys of perceived understanding, personal utility, and test-related distress after GS result disclosure.

Trust in prenatal exome sequencing for expectant families facing unexplained fetal anomalies.

Objective: Despite exome sequencing (ES) becoming increasingly incorporated into the prenatal setting, few studies have elucidated motivations for and trust in ES and genomic research among a diverse cohort of patients and their partners.

Methods: This is a qualitative study that involved semi-structured interviews with pregnant or recently pregnant individuals and their partners, interviewed separately, in the setting of ES performed through research for a fetal structural anomaly. All interview transcripts were coded thematically and developed by a multidisciplinary team.

Access to prenatal exome sequencing for fetal malformations: A qualitative landscape analysis in the US.

Objective: There is increasing evidence supporting the clinical utility of next generation sequencing for identifying fetal genetic disorders. However, there are limited data on the demand for and accessibility of these tests, as well as payer coverage in the prenatal context. We sought to identify clinician perspectives on the utility of prenatal exome sequencing (ES) and on equitable access to genomic technologies for the care of pregnancies complicated by fetal structural anomalies.

"Let's Just Wait Until She's Born": Temporal Factors That Shape Decision-Making for Prenatal Genomic Sequencing Amongst Families Underrepresented in Genomic Research.

Genomic sequencing has been increasingly utilized for prenatal diagnosis in recent years and this trend is likely to continue. However, decision-making for parents in the prenatal period is particularly fraught, and prenatal sequencing would significantly expand the complexity of managing health risk information, reproductive options, and healthcare access. This qualitative study investigates decision-making processes amongst parents who enrolled or declined to enroll in the prenatal arm of the California-based Program in Prenatal and Pediatric Genome Sequencing (P3EGS), a study in the Clinical Sequencing Evidence-Generating Research (CSER) consortium that offered whole exome sequencing for fetal anomalies with a focus on underrepresented groups in genomic research.

A qualitative study of obstacles to diaphragm and condom use in an HIV prevention trial in sub-Saharan Africa.

Consistent condom use and the substitution of condoms with potential HIV prevention methods of lower or unknown effectiveness are important concerns in the development of new prevention technologies. This qualitative study explored obstacles to consistent condom use with the diaphragm in MIRA, an HIV prevention trial in South Africa and Zimbabwe. We conducted 26 focus group discussions (FGDs) with 206 women and 7 FGDs and 10 in-depth interviews with 41 male partners of intervention-arm women.

User experiences and acceptability attributes of the diaphragm and lubricant gel in an HIV prevention trial in southern Africa.

Methods for Improving Reproductive Health in Africa (MIRA), a phase III HIV prevention trial, was conducted among 5039 Zimbabwean and South African women to test the Ortho All-Flex diaphragm and Replens(®) lubricant gel. Among the 2418 intervention group participants, 105 women who had completed the trial and 41 male partners participated in focus group discussions and in-depth interviews about the acceptability of the diaphragm and gel and their experiences using the study products. Women who participated in the qualitative study had exited the trial in the prior nine months, were HIV negative, and used the diaphragm and gel for 12-24 months.

Degrees of disclosure: a study of women's covert use of the diaphragm in an HIV prevention trial in sub-Saharan Africa.

In sub-Saharan Africa more women are infected with HIV/AIDS than men and new prevention methods are urgently needed. One major attribute of female-initiated HIV prevention methods is that they can be used covertly, without a male partner's knowledge. Using mixed methods, we explored the predictors and dimensions of covert use of the diaphragm in a randomized controlled trial that tested its effectiveness for HIV prevention.

Sexuality, HIV risk and potential acceptability of involving adolescent girls in microbicide research in Kisumu, Kenya.

Background: Current microbicide clinical trials primarily enroll adult participants; however, females under the age of 18, because of their high rates of HIV acquisition, represent an important population for future microbicide clinical research. We sought to understand the individual, family and community-level factors that may influence the acceptability of microbicide use and research involving adolescent girls.

Methods: We conducted 30 interviews with adolescent girls aged 14-17 and nine focus group discussions with adolescent girls, parents and community leaders in Kisumu, Kenya.

Barriers to fertility regulation: a review of the literature.

The evidence in the demographic and family planning literature of the range and diversity of the barriers to fertility regulation in many developing countries is reviewed in this article from a consumer perspective. Barriers are defined as the constraining factors standing between women and the realistic availability of the technologies and correct information they need in order to decide whether and when to have a child. The barriers include limited method choice, financial costs, the status of women, medical and legal restrictions, provider bias, and misinformation.

A comparison of cost-effectiveness of three protocols for diagnosis and treatment of gonococcal and chlamydial infections in women in Africa.

Background: The cost-effectiveness of different STD diagnosis and treatment approaches has not been evaluated previously.

Goals: The goals of the study were to compare the cost-effectiveness of "gold standard" care (GS), syndromic management (SM), and mass treatment (MT) protocols for the treatment of cervical gonococcal and chlamydial infections in a hypothetical model of 1 million women in Africa.

Study Design: A decision tree model was constructed for each of the protocols.