Antiretroviral Drugs Protect Against HIV-1 Infection in Heterosexuals

BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.MethodsWe conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.ResultsWe enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study.ConclusionsOral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.)

Childhood pneumonia diagnostics: community health workers’ and national stakeholders’ differing perspectives of new and existing aids

Background: Pneumonia heavily contributes to global under-five mortality. Many countries use community case management to detect and treat childhood pneumonia. Community health workers (CHWs) have limited tools to help them assess signs of pneumonia. New respiratory rate (RR) counting devices and pulse oximeters are being considered for this purpose. Objective: To explore perspectives of CHWs and national stakeholders regarding the potential usability and scalability of seven devices to aid community assessment of pneumonia signs. Design: Pile sorting was conducted to rate the usability and scalability of 7 different RR counting aids and pulse oximeters amongst 16 groups of participants. Following each pile-sorting session, a focus group discussion (FGD) explored participants’ sorting rationale. Purposive sampling was used to select CHWs and national stakeholders with experience in childhood pneumonia and integrated community case management (iCCM) in Cambodia, Ethiopia, Uganda and South Sudan. Pile-sorting data were aggregated for countries and participant groups. FGDs were audio recorded and transcribed verbatim. Translated FGDs transcripts were coded in NVivo 10 and analysed using thematic content analysis. Comparative analysis was performed between countries and groups to identify thematic patterns. Results: CHWs and national stakeholders across the four countries perceived the acute respiratory infection (ARI) timer and fingertip pulse oximeter as highly scalable and easy for CHWs to use. National stakeholders were less receptive to new technologies. CHWs placed greater priority on device acceptability to caregivers and children. Both groups felt that heavy reliance on electricity reduced potential scalability and usability in rural areas. Device simplicity, affordability and sustainability were universally valued. Conclusions: CHWs and national stakeholders prioritise different device characteristics according to their specific focus of work. The views of all relevant stakeholders, including health workers, policy makers, children and parents, should be considered in future policy decisions, research and development regarding suitable pneumonia diagnostic aids for community use

Usability of pulse oximeters used by community health and primary care workers as screening tools for severe illness in children under five in low resource settings: A cross-sectional study in Cambodia, Ethiopia, South Sudan, and Uganda.

Timely recognition and referral of severely ill children is especially critical in low-resource health systems. Pulse-oximeters can improve health outcomes of children by detecting hypoxaemia, a severity indicator of the most common causes of death in children. Cost-effectiveness of pulse-oximeters has been proven in low-income settings. However, evidence on their usability in community health settings is scarce.This study explores the usability of pulse-oximeters for community health and primary care workers in Cambodia, Ethiopia, South Sudan, and Uganda. We collected observational data, through a nine-task checklist, and survey data, using a five-point Likert scale questionnaire, capturing three usability aspects (effectiveness, efficiency, and satisfaction) of single-probe fingertip and multi-probe handheld devices. Effectiveness was determined by checklist completion rates and task completion rates per checklist item. Efficiency was reported as proportion of successful assessments within three attempts. Standardized summated questionnaire scores (min = 0, max = 100) determined health worker's satisfaction. Influencing factors on effectiveness and satisfaction were explored through hypothesis tests between independent groups (device type, cadre of health worker, country). Checklist completion rate was 78.3% [CI 72.6-83.0]. Choosing probes according to child age showed the lowest task completion rate of 68.7% [CI 60.3%-76.0%]. In 95.6% [CI 92.7%-97.4%] of assessments a reading was obtained within three attempts. The median satisfaction score was 95.6 [IQR = 92.2-99.0]. Significantly higher checklist completion rates were observed with single-probe fingertip devices (p<0.001) and children 12-59 months (p<0.001). We found higher satisfaction scores in South Sudan (p<0.001) and satisfaction varied slightly between devices. From a usability perspective single-probe devices for all age groups should be prioritized for scaled implementation. Further research on easy to use and accurate devices for infants is much needed

Five-number summary of satisfaction scores overall and per device group, country, and cadre.

Five-number summary of satisfaction scores overall and per device group, country, and cadre.</p

Description of checklist variables.

Timely recognition and referral of severely ill children is especially critical in low-resource health systems. Pulse-oximeters can improve health outcomes of children by detecting hypoxaemia, a severity indicator of the most common causes of death in children. Cost-effectiveness of pulse-oximeters has been proven in low-income settings. However, evidence on their usability in community health settings is scarce.This study explores the usability of pulse-oximeters for community health and primary care workers in Cambodia, Ethiopia, South Sudan, and Uganda. We collected observational data, through a nine-task checklist, and survey data, using a five-point Likert scale questionnaire, capturing three usability aspects (effectiveness, efficiency, and satisfaction) of single-probe fingertip and multi-probe handheld devices. Effectiveness was determined by checklist completion rates and task completion rates per checklist item. Efficiency was reported as proportion of successful assessments within three attempts. Standardized summated questionnaire scores (min = 0, max = 100) determined health worker’s satisfaction. Influencing factors on effectiveness and satisfaction were explored through hypothesis tests between independent groups (device type, cadre of health worker, country). Checklist completion rate was 78.3% [CI 72.6–83.0]. Choosing probes according to child age showed the lowest task completion rate of 68.7% [CI 60.3%-76.0%]. In 95.6% [CI 92.7%-97.4%] of assessments a reading was obtained within three attempts. The median satisfaction score was 95.6 [IQR = 92.2–99.0]. Significantly higher checklist completion rates were observed with single-probe fingertip devices (p</div

Effectiveness outcome: Frequency of full task completion, task completion rates with 95% confidence intervals and p-values.

Effectiveness outcome: Frequency of full task completion, task completion rates with 95% confidence intervals and p-values.</p

Flow chart participant recruitment.

a Confirmation that a medical device meets the safety, health and environmental protection requirements of the European Economic Area (EEA) [28]. b devices intended for monitoring possibly dangerous changes in vital parameters [29].</p

Frequency of task completion and task completion rates per checklist item.

Frequency of task completion and task completion rates per checklist item.</p

Frequency of task completion and task completion rates per checklist item, pairwise deletion.

Frequency of task completion and task completion rates per checklist item, pairwise deletion.</p

Efficiency outcome: Frequencies and percentages of successfull measurements.

Efficiency outcome: Frequencies and percentages of successfull measurements.</p