Capacity to Consent to Research Among Adolescent-Parent Dyads in Rakai, Uganda.

OBJECTIVES: To assess the cognitive capacity of early, middle, and late adolescents and their parents or guardians to provide informed consent to a population-based cohort study. STUDY DESIGN: Adolescent-parent/guardian dyads including 40 early (n = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study, an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research, a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t test and score differences between parent/guardian and adolescent dyads using two-sided paired t tests. RESULTS: Early adolescents (mean score, 28.8; 95% CI, 27.1-30.5) scored significantly lower (P < .01) than middle/late adolescents (32.4; 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference, -0.2; 95% CI, -1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference, 3.0; 95% CI, 1.2-4.8). CONCLUSIONS: The capacity of adolescents-of different ages and in diverse settings-to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.

Evaluation of telemedicine medical abortion using a no-test protocol in the Eastern Europe and Central Asian region: Evidence from Ukraine, Uzbekistan, and Azerbaijan.

OBJECTIVE: To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre-treatment in-person tests in Ukraine, Uzbekistan, and Azerbaijan. METHODS: We conducted an open-label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a telemedicine consultation with a study provider by phone or video. Medical abortion pills could be obtained by mail or courier or picked up at the study clinic or a pharmacy. Study providers contacted participants 1 week after mifepristone ingestion to assess abortion outcomes based on symptoms, and 3 weeks later to review the result of an at-home, high-sensitivity, urine pregnancy test. Participants were referred to in-person visit based on symptoms, urine pregnancy test results, or initiative by the participant. RESULTS: In all, 300 women participated in the study. Almost all participants received medical abortion medications the same day as their first contact with the study clinic, and the majority (n = 297, 99.0%) did not experience any problems receiving them. All except two women (0.67%) followed provider instructions on administration of medications. The majority of participants had a complete abortion without a procedure (Ukraine: n = 115, 95.8%; Uzbekistan: n = 127, 97.7%; Azerbaijan: n = 49, 98.0%), few had in-person visits (Ukraine: n = 30, 25.0%; Uzbekistan: n = 3, 2.3%; Azerbaijan: n = 4, 8.0%), and most were very satisfied or satisfied with the service (Ukraine: n = 116, 96%; Uzbekistan: n = 128, 98%; Azerbaijan: n = 45, 90%). No serious adverse events occurred. CONCLUSION: Telemedicine medical abortion using the no-test protocol is safe, feasible and acceptable for women in Ukraine, Uzbekistan, and Azerbaijan.

Magnitude and predictors of first-line antiretroviral therapy regimen change among HIV infected adults: A retrospective cross sectional study.

Background: Regimen change remains a significant challenge towards the achievement of human immunodeficiency virus (HIV) treatment success. In developing countries where limited treatment options are available, strategies are required to ensure the sustainability and durability of the starting regimens. Nevertheless, information regarding the rate and predictors of regimen change is limited in these settings. Objective: This study was undertaken to determine the prevalence and predictors of changes in ART regimens among patients initiating highly active antiretroviral therapy (HAART) at XX. Materials and methods: An institutional based retrospective cross-sectional study was conducted among adult naïve HIV patients who had initiated HAART at XX between 2010. Data were extracted by reviewing their medical charts using a pretested structured check-list. The Kaplan-Meier survival analyses were used to describe the probability of ARV regimen changes while Cox proportional hazard regression models were employed to identify the predictors of ARV regimen modifications. Data were analyzed using SPSS version 21 software, and statistical significant was deemed at p < 0.05. Results: A total of 770 patients were enrolled in this study of these 165 (21.43%) had their ART regimen modified at least once. Drug toxicity was the main reason for regimen change followed by TB comorbidity, and treatment failure. Positive baseline TB symptoms (aHR = 1.63, p = 0.037), and Zidovudine based regimen (aHR = 1.76, p = 0.011) as compared to Stavudine based regimen were at higher risk of ART modification. Conversely, urban residence, baseline World Health organization (WHO) stage 2 as compared to WHO stage 1, baseline CD4 count ≥301 as compared to CD4 count ≤200 were at lower risk of ART modification. Conclusion: The rate of initial HAART regimen change was found to be high. Thus, less toxic and better tolerated HIV treatment options should be available and used more frequently. Moreover, early detection and initiation of ART by the government is highly demanded to maximize the benefit and reduce risk of ART modifications.

HIV combination prevention and declining orphanhood among adolescents, Rakai, Uganda, 2001-18: an observational community cohort study.

BACKGROUND: Orphanhood increased markedly in the 1980s and 1990s in sub-Saharan Africa because of HIV-related mortality. Little is known about the contribution of HIV interventions, such as antiretroviral therapy (ART) and male medical circumcision, to more recent trends in orphanhood. In this study, we examined trends over time in maternal-only, paternal-only, and double orphanhood among adolescents before and after ART and male medical circumcision became widely available in the Rakai region of south-central Uganda. We sought to understand the association between adolescent orphanhood and HIV combination prevention (community-level ART use and prevalence of male medical circumcision). We hypothesised that increasing combination prevention, including greater use of ART and higher prevalence of male medical circumcision, would be associated with a lower probability of orphanhood. METHODS: We examined the prevalence of orphanhood among adolescents aged 15-19 years, before and after roll-out of ART in mid-2004 and male medical circumcision in 2007, using data from 28 continuously followed communities within the Rakai Community Cohort Study. We used multinomial logistic regression with clustered SEs to estimate adjusted relative risk ratios (RRs) for maternal-only, paternal-only, and double orphanhood compared with non-orphanhood over 11 survey rounds between 2001 and 2018. Controlling for community HIV prevalence, household socioeconomic status, and adolescent age, we examined the association between community prevalence of ART use among people living with HIV and prevalence of male circumcision, including traditional circumcision. The primary outcome was orphanhood among adolescents aged 15-19 years. FINDINGS: Orphanhood declined from 52% (920 of 1768 participants) in 2001-02 to 23% (592 of 2609 participants) by 2016-18 (p<0·0001), while double orphanhood declined from 20% (346 of 1768 participants) to 3% (86 of 2609 participants) (p<0·0001). Community prevalence of ART use among people living with HIV increased from 11% (105 of 945 participants) in 2005-06 to 78% (1163 of 1485 participants) in 2016-18. Male circumcision rates rose from 19% (147 of 790 participants) in 2005-06 to 65% (3535 of 5433 participants) in 2016-18. In the multinomial logistic regression model, a 10% increase in community prevalence of ART use was associated with a decrease in maternal orphanhood (adjusted relative RR 0·90, 95% CI 0·85-0·95) and double orphanhood (0·80, 0·75-0·85). In the post-ART era, a 10% increase in the community prevalence of male circumcision was associated with a decrease in paternal orphanhood (2005-18, adjusted relative RR 0·92, 0·87-0·97) and double orphanhood (0·91, 0·85-0·98). INTERPRETATION: Widespread availability and uptake of HIV combination prevention was associated with marked reductions in orphanhood among adolescents. Reductions in orphanhood promise improved health and social outcomes for young people. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, and the Division of Intramural Research of the National Institute for Allergy and Infectious Diseases.

Immunologic and Clinical Failure of Antiretroviral Therapy in People Living with Human Immunodeficiency Virus within Two Years of Treatment.

BACKGROUND: Early initiation of highly active antiretroviral therapy (HAART) decreases human immunodeficiency virus- (HIV-) related complications, restores patients' immunity, decreases viral load, and substantially improves quality of life. However, antiretroviral treatment failure considerably impedes the merits of HAART. OBJECTIVE: This study is aimed at determining the prevalence of immunologic and clinical antiretroviral treatment failure. METHODS: A cross-sectional study design using clinical and immunologic treatment failure definition was used to conduct the study. Sociodemographic characteristics and clinical features of patients were retrieved from patients' medical registry between the years 2009 and 2015. All patients who fulfilled the inclusion criteria in the study period were studied. Predictors of treatment failure were identified using Kaplan-Meier curves and multivariable Cox regression analysis. Data analysis was done using SPSS version 21 software, and the level of statistical significance was declared at a p value < 0.05. RESULTS: A total of 770 were studied. The prevalence of treatment failure was 4.5%. The AZT-based regimen (AHR = 16.95, 95% CI: 3.02-95.1, p = 0.001), baseline CD4 count ≥ 301 (AHR = 0.199, 95% CI: 0.05-0.76, p = 0.018), and bedridden during HAART initiation (AHR = 0.131, 95% CI: 0.029-0.596, p = 0.009) were the predictors of treatment failure. CONCLUSION: The prevalence of treatment failure was lower with the risk being higher among patients on the AZT-based regimen. On the other hand, the risk of treatment failure was lower among patients who started HAART at baseline CD4 count ≥ 301 and patients who were bedridden during HAART initiation. We recommend further prospective, multicenter cohort studies to be conducted to precisely detect the prevalence of treatment failure using viral load determination in the whole country.