Amber Abrams

High Rates of Unprotected Sex occurring among HIV-Positive Individuals in a Daily Diary Study in South Africa: The Role of Alcohol Use

Objectives:The objectives of this study were to assess the prevalence of unprotected sex and to examine the association between alcohol consumption before sex and unprotected sex among HIV-positive individuals in Cape Town, South Africa. Methods:For 42 days, daily phone interviews assessed daily sexual behavior and alcohol consumption. Logistic and Poisson generalized estimating equation models were used to examine associations between alcohol consumption before sex and subsequent unprotected sex. Results:During the study which yielded 3035 data points, 58 HIV-positive women and 24 HIV-positive men drank an average of 6.13 drinks when they drank and reported 4927 sex events, of which 80.17% were unprotected. More than half (58%) of unprotected sex events were with HIV-negative partners or with partners with unknown HIV status. Extrapolating from the data using likelihood of infection per act estimates, we calculated that an estimated 2.95 incident HIV infections occurred during the study. Drinking alcohol before sex by the female partner or the male partner, or by both partners increased the proportion and number of subsequent unprotected sex events. However, these associations held only when the quantity of alcohol consumed corresponded to moderate or higher risk drinking. Conclusions:Among HIV positive individuals, engaging in moderate or higher risk drinking before sex increases the likelihood and rate of unprotected sex. Prevention efforts need to address reducing alcohol-involved unprotected sex among HIV-positive persons.

The role of alcohol use in antiretroviral adherence among individuals living with HIV in South Africa: Event-level findings from a daily diary study

OBJECTIVE Using daily diary methods, we aimed to test the hypothesis that at the event-level consuming alcohol increases the likelihood that antiretrovirals (ARV) will be missed on a particular day. METHODS This prospective cohort study of 74 (52 female, 22 male) people living with HIV (PLHIV) in South Africa collected event-level data on ARV adherence and alcohol consumption using structured daily phone interviews over a period of 42days generating 2718 data points. We used generalized estimating equations (GEE) analyses to assess univariate and multivariate associations between alcohol and adherence, controlling for sociodemographics and testing for effect modification. RESULTS Controlling for sociodemographics, each alcohol measure was a statistically significant predictor of non-adherence on a particular day; any drinking compared to no drinking (daytime: AOR=3.18, 95% CI=2.25-4.49; evening: AOR=3.43, 95% CI=2.12-5.53), consuming more alcohol than one normally consumes (daytime: AOR=1.06, 95% CI=1.02-1.11; evening: AOR=1.10, 95% CI=1.05-1.15), and drinking at low to moderate risk level (daytime: 4.29, 95% CI=2.81-6.56; evening: AOR=4.24, 95% CI=2.38-7.54) and high to very high risk levels (daytime: AOR=2.31, 95% CI=1.56-3.42; evening: AOR=3.08, 95% CI=1.91-4.98) were all significantly related to missing ARVs in the daytime and evening. CONCLUSIONS These data provide support for an event-level relationship between alcohol and non-adherence. Interventions that mitigate alcohol use among people on ARVs or provide strategies to maintain optimal adherence among those who drink are needed.

The Pan African Clinical Trials Registry: year one data analysis of the only African member of the World Health Organization Network of Primary Registries

Background Prospective registration in a clinical trial registry is mandatory for all clinical trial research intended for publication in any International Committee of Medical Journal Editors member journal. With the launch of the Pan African Clinical Trial Registry (PACTR) in September 2009, the first African member of the World Health Organization (WHO) Network of Primary Registers came into being as the only registry dedicated specifically to trials on the African continent.

A Pan African Clinical Trials Registry for the specific needs of triallists on the continent.

Clinical trials provide the best evidence for which health care interventions work, which do not, and which may be harmful. Ideally we aim to base our clinical practice on the results from well-conducted trials. For us to be able to do so, all trial reports must be available in the public domain and accurately reflect the methods and the results of clinical trials.

Series: Clinical Epidemiology in South Africa. Paper 2: Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Primary care clinical practice guidelines in South Africa: qualitative study exploring perspectives of national stakeholders

BackgroundClinical practice guidelines (CPGs) are common tools in policy and clinical practice informing clinical decisions at the bedside, governance of health facilities, health insurer and government spending, and patient choices. South Africa’s health sector is transitioning to a national health insurance system, aiming to build on other primary health care initiatives to transform the previously segregated, inequitable services. Within these plans CPGs are an integral tool for delivering standardised and cost effective care. Currently, there is no accepted standard approach to developing, adapting or implementing CPGs efficiently or effectively in South Africa. We explored the current players; drivers; and the context and processes of primary care CPG development from the perspective of stakeholders operating at national level.MethodsWe used a qualitative approach. Sampling was initially purposeful, followed by snowballing and further sampling to reach representivity of primary care service providers. Individual in-depth interviews were recorded and transcribed verbatim. We used thematic content analysis to analyse the data.ResultsWe conducted 37 in-depth interviews from June 2014–July 2015. We found CPG development and implementation were hampered by lack of human and funding resources for technical and methodological work; fragmentation between groups, and between national and provincial health sectors; and lack of agreed systems for CPG development and implementation. Some CPG contributors steadfastly work to improve processes aiming to enhance communication, use of evidence, and transparency to ensure credible guidance is produced. Many interviewed had shared values, and were driven to address inequity, however, resource gaps were perceived to create an enabling environment for commercial interests or personal agendas to drive the CPG development process.ConclusionsOur findings identified strengths and gaps in CPG development processes, and a need for national standards to guide CPG development and implementation. Based on our findings and suggestions from participants, a possible way forward would be for South Africa to have a centrally coordinated CPG unit to address these needs and aspects of fragmentation by devising processes that support collaboration, transparency and credibility across sectors and disciplines. Such an initiative will require adequate resourcing to build capacity and ensure support for the delivery of high quality CPGs for South African primary care.

Supporting registration of child-focused clinical trials in Africa: The Child Strategy project

Child-focused health care workers are compelled to prescribe medicines that lack adequate dosage guidelines for children, as dosing is often derived from data extrapolated from adult studies. Given that the pharmacokinetics and pharmacodynamics of treatments are often unknown for children, and that effectiveness may vary according to age, developmental stage and body size, there is an urgent need to study diagnostic and therapeutic interventions in children to increase the evidence base. A 2005 report of African HIV trial activity identified 77 randomised controlled HIV/AIDS trials prior to 2004. Analysis revealed poor representation of children and adolescents. Currently there is no database dedicated to collating child-focused clinical research for the African continent. Our aim is to summarise evolving efforts for such a resource.

Growing Everyday: The Pan African Clinical Trials Registry

The Pan African Clinical Trial Registry (http://www.pactr.org), established as the AIDS, Tuberculosis and Malaria Registry (ATM) has developed into the registry of choice for African trials. The register was formally launched as a World Health Organization primary register in September 2009. Data analysis shows that registry applications have increased steadily since then, as has representation throughout the region. New developments to the registry include the implementation of a real‐time Global Information Systems map on the portal and development of Standard Operating Procedures while focused efforts on dissemination continue. http://www.pactr.org is now well‐placed to provide a valuable resource for researchers, clinicians, policy‐makers and consumers on the continent.

Journal editors must play their part in checking timing of clinical trial registration

Clinical trial registration is pivotal to understanding the research landscape and for ensuring research accountability. But what do we do when protocols to ensure public access to information are in place but chains of responsibility fail? Prospective clinical trial registration is mandated by the International Committee of Medical Journal Editors’ (ICMJE) uniform requirements for manuscripts as a pre-condition for publication.1 …