Trials In sub-Saharan Africa Research Articles

Cancer Research in sub-Saharan Africa: Progress in closing the gap

Cancer presents an escalating challenge in Sub-Saharan Africa (SSA), necessitating strategic interventions grounded in regionally relevant evidence-based medicine. Informed decision-making is critical to formulate effective strategies for cancer prevention, diagnosis, funding, and treatment within the SSA population. The aim of this study is to highlight ongoing clinical trials in SSA, emphasizing the continuous initiatives aimed at filling existing knowledge gaps. Further, the study seeks to assess whether SSA is progressing or stagnating in the global landscape of cancer research. A comprehensive review of research papers and online registries on clinical trials was executed, focusing on English-language journal articles retrieved from the PubMed database. Additionally, a quantitative, web-based, retrospective review was conducted on registered cancer studies in SSA over the past decade (2000-2023) from ClinicalTrials.gov and the Pan African Clinical Trials Registry (PACTR) databases. The review resulted in the inclusion of 71 articles from PubMed, alongside 104 and 140 clinical trials from ClinicalTrials.gov and PACTR databases, respectively. Aggregate findings from PubMed and clinical trial databases revealed that East Africa is the predominant contributor (37%) to cancer clinical trials, whereas Central Africa exhibited the lowest contribution (4%). Notably, PubMed indicated a predominant focus on cervical cancer in clinical trials. Between 2000 and 2015, less than 4% of global cancer clinical trials listed on ClinicalTrials.gov were performed in SSA; in subsequent years, there was an observable increase in the percentage of total trials performed in SSA. Analyses of funding sources revealed that 45% and 32% of clinical trials in SSA were supported by the United States and the United Kingdom, respectively. In the last two decades, the formation of entities like the African Consortium for Cancer Clinical Trials, spearheaded by BIO Ventures for Global Health in partnership with African ministries of health, cancer hospitals, private industry, research institutions, and global oncology experts, contributed to increasing the effective implementation of multicenter clinical trials in Africa. Noteworthy instances, such as the Burkitt's lymphoma and HypoAfrica studies, serve as examples of the results arising from these collaborative initiatives, reflecting substantial progress within SSA’s cancer research landscape.

An unclosed loop: Perspectives of community engagement in infectious disease clinical trials in sub-Saharan Africa.

Community engagement (CE) is pertinent to ethically and scientifically rigorous infectious disease clinical trials in sub-Saharan Africa (SSA). However, there are critiques that CE is not properly embedded in research processes and that there is uncertainty about what CE entails. The aim of this study was to gain an understanding of CE in infectious disease clinical trials in SSA, specifically factors affecting CE and existing strategies for engaging with communities. Semi-structured telephone interviews were conducted with 20 community and clinical trial (CT) stakeholders who worked in SSA. The audio-recorded interviews were transcribed verbatim and analysed inductively using thematic analysis. Themes are as follows: 1) Communities are abandoned research-entities-a disconnect between scientific teams and communities was observed and knowledge translation was not prioritised at the community-level. 2) Us and them: community engagement teams vs investigators-CE teams expressed that researchers did not account for CE processes and often did not involve CE staff in their planning, and felt that their roles were not valued. 3) Ethical considerations: concerns and gaps-there were concerns that procedures were not standardised and that ethics processes were not adhered to. 4) Opportunities for improved CE practices-training needs were expressed, including for standardised practices, ethics, and for developing a holistic understanding of collaborating with communities. CE role players require intensive training to ensure ethical CE and that communities are treated with dignity. This includes 1) using collaborative strategies involving research and CE staff, 2) protocol-adherence that recognises CE as pertinent, 3) viewing communities as complex and building relationships that are sustainable, and 4) ensuring that knowledge translation is considered at a community-level. Further research is necessary to investigate potential training programmes that integrate these elements.

Doxycycline vs Hydroxychloroquine + Azithromycin in the Management of COVID-19 Patients: An Open-Label Randomized Clinical Trial in Sub-Saharan Africa (DOXYCOV).

Objective We aimed to compare the safety and efficacy of a doxycycline-based regimen against Cameroon National Standard Guidelines (hydroxychloroquine plus azithromycin) for the treatment of mild symptomatic COVID-19. Methods We conducted an open-label, randomized, non-inferiority trialin Cameroon comparing doxycycline 100 mg, twice daily for seven days versus hydroxychloroquine400 mg daily for five days and azithromycin 500 mg at day 1 and 250 mg from day 2 through 5in mild COVID-19 patients. Clinical recovery, biological parameters, and adverse events were assessed. The primary outcome was the proportion of clinical recovery on days 3, 10, and 30. Non-inferiority was determined by the clinical recovery rate between protocols with a 20-percentage points margin. Results One hundred and ninety-four participants underwent randomization and were treated either with doxycycline (n = 97) or hydroxychloroquine-azithromycin (n = 97). On day 3, 74/92 (80.4%) participants on doxycycline versus 77/95 (81.1%) on hydroxychloroquine-azithromycin-based protocols were asymptomatic (p = 0.91). On day 10, 88/92 (95.7%) participants on doxycycline versus 93/95 (97.9%) on hydroxychloroquine-azithromycin were asymptomatic (p = 0.44). On day 30, all participants were asymptomatic. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) polymerase chain reaction (PCR) test was negative on day 10 in 60/92 (65.2%) participants who were assigned to doxycycline and in 63/95 (66.3%) participants who were assigned to hydroxychloroquine-azithromycin. None of the participants were admitted for worsening of the disease after treatment initiation. Conclusion Doxycycline 100 mg twice daily for seven days proved to be safe and non-inferior in terms of efficacy when compared to hydroxychloroquine-azithromycinfor preventing clinical worsening of mild symptomatic or asymptomatic COVID-19 and achieving virological suppression.

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

IntroductionDigital health has gained traction in research and development, and clinical decision support systems. The COVID-19 pandemic accelerated the adoption of decentralised clinical trials (DCTs) as a mitigation and efficiency...

Advancing Access to Diagnostic Tools Essential for Universal Health Coverage and Antimicrobial Resistance Prevention: An Overview of Trials in Sub-Saharan Africa.

We introduce the Antimicrobial Resistance Diagnostic Use Accelerator program, and the articles in this Supplement, which cover the program in 3 sub-Saharan Africa countries.

Outcomes of Wilms tumor therapy in Lilongwe, Malawi, 2016-2021: Successes and ongoing research priorities.

Wilms tumor therapy in low- and middle-income countries (LMICs) relies on treatment protocols adapted to resource limitations, but these protocols have rarely been evaluated in real-world settings. Such evaluations are necessary to identify high-impact research priorities for clinical and implementation trials in LMICs. The purpose of this study was to identify highest priority targets for future clinical and implementation trials in sub-Saharan Africa by assessing outcomes of a resource-adapted treatment protocol in Malawi. We conducted a retrospective cohort study of children treated for Wilms tumor with an adapted SIOP-backbone protocol in Lilongwe, Malawi between 2016 and 2021. Survival analysis assessed variables associated with poor outcome with high potential for future research and intervention. We identified 136 patients, most commonly with stage III (n=35; 25.7%) or IV disease (n=35; 25.7%). Two-year event-free survival (EFS) was 54% for stage I/II, 51% for stage III, and 13% for stage IV. A single patient with stage V disease survived to 1year. Treatment abandonment occurred in 36 (26.5%) patients. Radiotherapy was indicated for 55 (40.4%), among whom three received it. Of these 55 patients, 2-year EFS was 31%. Of 14 patients with persistent metastatic pulmonary disease at the time of nephrectomy, none survived to 2years. Notable variables independently associated with survival were severe acute malnutrition (hazard ratio [HR]: 1.9), increasing tumor stage (HR: 1.5), and vena cava involvement (HR: 3.1). High-impact targets for clinical and implementation trials in low-resource settings include treatment abandonment, late presentation, and approaches optimized for healthcare systems with persistently unavailable radiotherapy.

A randomized controlled trial evaluating the effectiveness of narrative therapy on resilience of orphaned and abandoned children fostered in SOS children’s village

ABSTRACT Background: Narrative Therapy is an efficacious treatment approach widely practiced for various psychological conditions. However, few studies have examined its effectiveness on resilience, a robust determinant of one’s mental health, and there has been no randomized controlled trial in sub-Saharan Africa. Objective: This study sought to evaluate the efficacy of narrative therapy for the resilience of orphaned and abandoned children in Rwanda. Method: This study was a ‘parallel randomized controlled trial’ in which participants (n = 72) were recruited from SOS Children’s Village. Half of the participants (n = 36) were randomly allocated to the intervention group and the rest to the delayed narrative therapy group. For the intervention group, children attended ten sessions (55 min each) over 2.5 months. Data were collected using the Child and Youth Resilience Measure (CYRM) and analyzed using mixed ANOVA within SPSS version 28. Result: The results from ANOVA indicated a significant main effect of time and group for resilience total scores. Of interest, there was a significant time by group interaction effect for resilience. Pairwise comparison analyses within-group showed a significant increase in resilience in the intervention group, and the effect size was relatively large in this group. Conclusion: Our findings highlight the notable efficacy of narrative therapy for children’s resilience in the intervention group. Therefore, health professionals and organizations working with orphaned and abandoned children will apply narrative therapy to strengthen their resilience and improve mental health. Trial registration: Pan African Clinical Trial Registry identifier: PACTR202107499406828..

Integrating Gender-Based Violence Screening and Support into the Research Clinic Setting: Experiences from an HIV Prevention Open-Label Extension Trial in Sub-Saharan Africa

HIV and gender-based violence (GBV) are syndemic in sub-Saharan Africa and provision of support for participants who disclose GBV constitutes part of comprehensive care. Consequently, a process was undertaken to develop, implement, and evaluate standard operating procedures (SOPs) in MTN-025/HOPE, a study of the dapivirine vaginal ring for HIV prevention. The SOP was developed using needs assessment surveys in addition to World Health Organization (WHO) guidelines and other literature. Sites tailored and implemented the SOP through HOPE implementation. At study end, staff reported increased training 32/35 (91.43%); improved confidence (18/26; 69.23%); and improved vicarious trauma prevention onsite (17/28; 60.71%). Leadership reported increased staff competence in GBV response. Obstacles included limited referral organizations and time for follow-up, continued training needs, and cultural norms. Development and implementation of an SOP is a feasible strategy to build a GBV response to improve health systems and support sustained effective use of HIV prevention products.

Stroke Prevention with Hydroxyurea Enabled through Research and Education: A Phase 2 Primary Stroke Prevention Trial in Sub-Saharan Africa

Introduction: Stroke is a severe complication of sickle cell anemia (SCA), with devastating sequelae. Transcranial Doppler (TCD) ultrasonography predicts stroke risk, but implementing TCD screening with suitable treatment for primary stroke prevention in low-resource environments remains challenging. SPHERE (NCT03948867) is a prospective phase 2 open-label hydroxyurea trial for SCA in Tanzania. Methods: After formal training and certification, local personnel screened children 2–16 years old; those with conditional (170–199 cm/s) or abnormal (≥200 cm/s) time-averaged mean velocities (TAMVs) received hydroxyurea at 20 mg/kg/day with dose escalation to maximum tolerated dose (MTD). The primary study endpoint is change in TAMV after 12 months of hydroxyurea; secondary endpoints include SCA-related clinical events, splenic volume and function, renal function, infections, hydroxyurea pharmacokinetics, and genetic modifiers. Results: Between April 2019 and April 2020, 202 children (average 6.8 ± 3.5 years, 53% female) enrolled and underwent TCD screening; 196 were deemed eligible by DNA testing. Most had numerous previous hospitalizations and transfusions, with low baseline hemoglobin (7.7 ± 1.1 g/dL) and %HbF (9.3 ± 5.4%). Palpable splenomegaly was present at enrollment in 49 (25%); average sonographic splenic volume was 103 mL (range 8–1,045 mL). TCD screening identified 22% conditional and 2% abnormal velocities, with hydroxyurea treatment initiated in 96% (45/47) eligible children. Conclusion: SPHERE has built local capacity with high-quality research infrastructure and TCD screening for SCA in Tanzania. Fully enrolled participants have a high prevalence of elevated baseline TCD velocities and splenomegaly. SPHERE will prospectively determine the benefits of hydroxyurea at MTD for primary stroke prevention, anticipating expanded access to hydroxyurea treatment across Tanzania.

Breast cancer screening in sub-Saharan Africa: a systematic review and ethical appraisal

BackgroundThe aim of this systematic review was to evaluate the evidence and clinical outcomes of screening interventions and implementation trials in sub-Saharan Africa (SSA) and also appraise some ethical issues related to screening in the region through quantitative and qualitative narrative synthesis of the literature.MethodsWe searched Pubmed, OvidMEDLINE, Embase, and Web of Science to identify studies published on breast cancer screening interventions and outcomes in SSA. Descriptive statistics were used to summarize the frequency and proportions of extracted variables, and narrative syntheses was used to evaluate the clinical outcomes of the different screening modalities. The mixed methods appraisal tool was used to assess the quality of studies included in the review.ResultsFifteen studies were included, which consisted of 72,572 women in ten countries in SSA. 63% (8/15) of the included publications evaluated Clinical Breast Examination (CBE), 47% (7/15) evaluated mammography and 7% (1/15) evaluated ultrasound screening. The cancer detection rate was < 1/1000 to 3.3/1000 and 3.3/100 to 56/1000 for CBE and mammography screening respectively. There was a lot of heterogeneity in CBE methods, target age for screening and no clear documentation of screening interval. Cost-effective analyses showed that CBE screening linked to comprehensive cancer care is most cost effective. There was limited discussion of the ethics of screening, including the possible harms of screening in the absence of linkage to care. The gap between conducting good screening program and the appropriate follow-up with diagnosis and treatment remains one of the major challenges of screening in SSA.DiscussionThere is insufficient real-world data to support the systematic implementation of national breast cancer screening in SSA. Further research is needed to answer important questions about screening, and national and international partnerships are needed to ensure that appropriate diagnostic and treatment modalities are available to patients who screen positive.

Defining clinical trial quality from the perspective of resource-limited settings: A qualitative study based on interviews with investigators, sponsors, and monitors conducting clinical trials in sub-Saharan Africa.

BackgroundIncreasing clinical trial cost and complexity, as well as a high waste of clinical trial investment over the past decades, have changed the way clinical trial quality is managed. Recent evidence has highlighted that the lack of a clear clinical trial quality definition may have contributed to previous inefficiencies. This study aims to support the understanding of what clinical trial quality entails from the perspective of resource-limited settings.Methodology/Principal findingsWe conducted 46 semi-structured interviews involving investigators, sponsors, and monitors with experience in conducting clinical trials in 27 countries in sub-Saharan Africa. The questionnaire addressed the overall meaning of clinical trial quality and a conclusive clinical trial quality definition, as well as specific aspects of resource-limited settings across the clinical trial process. We held the interviews either in person, via Skype or by phone. They were recorded and transcribed verbatim, and we performed the analysis using The Framework Method. The analysis of clinical trial quality definitions resulted in 11 elements, which were summarised into a clinical trial quality concept consisting of two components: 1) clinical trial quality building factors (Scientific factors and Moral factors) and 2) promoting factors (Context adaptation; Infrastructure; Partnership; Operational excellence; Quality system). 12 resource-limited settings specific themes were identified. These themes were all categorised under the promoting factors "Context adaptation", "Infrastructure", and "Partnership".Conclusions/SignificanceWe found that in order to enable comprehensive clinical trial quality management, clinical trial quality should be defined by a multidimensional concept that includes not only scientific and ethical, but also quality-promoting factors. Such a concept is of general relevance and not limited to clinical trials in resource-limited settings, where it naturally carries particular weight. In addition, from the perspective of sub-Saharan Africa, we identified specific categories that appear to be critical for the conduct of clinical trials in resource-limited settings, and we propose respective changes to a particular existing clinical trial quality framework (i.e., INQUIRE).

Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University

BackgroundSub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in research has led to advances in improvements in outcomes, a lot still remains to be done to build research capacity in health. Like many other regions in the world, Sub-Saharan Africa suffers from a critical shortage of biostatisticians and clinical trial methodologists.MethodsFunded through a Fogarty Global Health Training Program grant, the Faculty of Medicine and Health Sciences at Stellenbosch University in South Africa established a new Masters Program in Biostatistics which was launched in January 2017. In this paper, we describe the development of a biostatistical and clinical trials collaboration Module, adapted from a similar course offered in the Health Research Methodology program at McMaster University.DiscussionGuided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January–November 2018 to 2021. We expect that this Module can provide an example of how to improve biostatistical and clinical trial collaborations and accelerate research capacity building in low-resource settings.Funding sourceFogarty International Center of the National Institutes of Health.

ART initiation among women newly diagnosed with HIV in a contraceptive trial in sub-Saharan Africa

ABSTRACT Current guidelines recommend starting antiretroviral therapy (ART) as soon as possible after HIV diagnosis to reduce morbidity, mortality and onward HIV transmission. We examined factors influencing ART initiation by women who seroconverted during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. ECHO, conducted between 2015 and 2018, enrolled HIV-negative, sexually active women, aged 16–35 years, from four African countries. Follow-up was 12–18 months, with quarterly HIV testing. Women with incident HIV infection received extensive counselling by trial staff and referral to local facilities for HIV care. Of 304 women with ≥90 days follow-up time since HIV diagnosis, 186(61.2%) initiated ART within 90 days, 69(22.7%) initiated after 90 days, and 49(16.1%) had not initiated by the end of the study. There were no statistically significant differences in characteristics among women who initiated ART ≤90 days versus those who did not. Frequent reasons for delayed or non-initiation of ART included not feeling ready to start ART and being newly diagnosed. In a large clinical trial, ART initiation was modest within 90 days of HIV diagnosis and grew to 84% with longer observation. Despite extensive counselling on the importance of early ART initiation, personal barriers delayed some women from starting ART.

Likely clinical depression and HIV-related decline in antiretroviral therapy untreated women who seroconverted during participation in microbicide trials in sub-Saharan Africa.

Depression worsens HIV outcomes in populations treated with antiretroviral therapy (ART) medications. Data are limited on the relationship between depression and HIV in untreated populations in sub-Saharan Africa. We aimed to identify associations between likely clinical depression, alcohol use, social support by partners, and HIV viral load (VL) among ART untreated women who recently became HIV positive and enrolled in the Microbicide Trials Network (MTN)-015 study. Analyses used cross-sectional data collected at baseline in MTN-015. Participants in this analysis (N = 190) enrolled from other MTN trials were not receiving ART and provided data on their HIV disclosure status to their husband or male partner and alcohol use behavior. The dependent variable, VL, was categorized as: low (≤400 RNA copies/mL; 9.1% of participants), medium (401-20,000 RNA copies/mL; 48.8%), and high (>20,000 RNA copies/mL; 42.0%). Depression was assessed using eight items from Hopkins Symptom Checklist; a cutoff of ≥1.75 indicated likely clinical depression. Independent variables with a significance of p ≤ 0.05 in unadjusted regressions were included in a regression adjusted for age, education, and time since seroconversion. Depressive symptoms were positively associated with high VL, in the adjusted regression (OR = 1.80; 95% CI = 1.07-3.01). Results suggest that likely having clinical depression may have a biological relationship with HIV disease progression.

\u201cYou would not be in a hurry to go back home\u201d: patients\u2019 willingness to participate in HIV/AIDS clinical trials at a clinical and research facility in Kampala, Uganda

BackgroundFew studies have examined factors associated with willingness of people living with HIV (PLHIV) to participate in HIV treatment clinical trials in Sub-Saharan Africa. We assessed the factors associated with participation of PLHIV in HIV treatment clinical trials research at a large urban clinical and research facility in Uganda.MethodsA mixed methods study was conducted at the Infectious Diseases Institute (IDI), adult HIV clinic between July 2016 and January 2017. Data were collected using structured questionnaires, focused group discussions with respondents categorised as either participated or never participated in clinical trials and key informant interviews with IDI staff. A generalized linear model with a logit link function was used for multivariate analyses while the qualitative data were summarized using a thematic approach.ResultsWe enrolled a total of 202 and analysed 151 participants, 77 (51%) of whom were male with mean age of 41 years. The majority 127 (84%) expressed willingness to participate in treatment clinical trials if given an opportunity. At bivariate analysis, willingness to participate was significantly associated with respondents’ perception of a satisfactory compensation package (P-value < 0.002, 0.08–0.56), special status accorded (P-value < 0.001, 0.05–0.39) and belief that their health status would improve (P-value< 0.08, 0.03–0.58) while on the clinical trial. At multivariate analysis, a satisfactory compensation package (P-value< 0.030, 0.08–0.88) and special status accorded in clinical trials (P-value< 0.041, 0.01–0.91) remained significant. The qualitative data analysis confirmed these findings as participants valued the privilege of jumping the clinic waiting queues and spending less time in clinic, the wide range of free tests offered to trial participants, unrestricted access to senior physicians and regular communication from study team. Additionally, free meals offered during clinic visits meant that participants were not in a hurry to go back home. Barriers to participation included the perception that new drugs were being tested on them, fear of side effects like treatment failure and the uncertainty about privacy of their data.ConclusionWe found overwhelming willingness to participate in HIV treatment clinical trials. This was largely extrinsically influenced by the perceived material and health-related benefits. Investigators should pay attention to participants’ concerns for benefits which may override the need to understand study procedures and risks.

THU408 - Characteristics of adults with difficult-to-treat hepatitis C virus genotype subtype 4r infection in Rwanda: a secondary analysis of a clinical trial in Sub-Saharan Africa (shared study)

THU408 - Characteristics of adults with difficult-to-treat hepatitis C virus genotype subtype 4r infection in Rwanda: a secondary analysis of a clinical trial in Sub-Saharan Africa (shared study)

Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study

BackgroundAn effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials.MethodsWe present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi.ResultsPrimary challenges are grouped under study initiation, study population, study implementation, and cultural issues. The lessons learned primarily deal with regulatory system and operational barriers, and recommendations can be applied to other human experimental trials in low- and middle-income countries, specifically in sub-Saharan Africa.ConclusionThis study demonstrated that initiating and implementing human experimental trials in sub-Saharan Africa can be challenging. However, solutions exist and successful execution requires careful planning, ongoing evaluation, responsiveness to new developments, and oversight of all trial operations.

Challenges of HIV Lymphoma Clinical Trials in Africa: Lessons From the AIDS Malignancy Consortium 068 Study.

The purpose of this article is to describe lessons from the first lymphoma clinical trial conducted by the AIDS Malignancy Consortium (AMC) in sub-Saharan Africa (SSA). AMC-068 was a randomized phase II comparison of intravenous versus oral chemotherapy for HIV-positive diffuse large B-cell lymphoma. Opening in 2016, AMC-068 planned to enroll 90 patients (45 per arm) in Kenya, Malawi, Uganda, and Zimbabwe over 24 months and follow patients for 24 months to assess overall survival. In 2018, the study closed after screening 42 patients but enrolling only 7. Challenges occurred during protocol development, pre-activation, and postactivation. During protocol development (2011-2012), major obstacles were limited baseline data to inform study design; lack of consensus among investigators and approving bodies regarding appropriateness of the oral regimen and need for randomized comparison with cyclophosphamide, doxorubicin, vincristine, and prednisone; and heterogeneity across sites in local standards for diagnosis, staging, and treatment. During pre-activation (2012-2016), challenges included unexpected length and layers of regulatory approval across multiple countries, need to upgrade pathology capacity at sites, need to augment existing chemotherapy infusion capacity at sites, and procurement issues for drugs and supplies. Finally, during postactivation (2016-2018), challenges included long delays between symptom onset and screening entry for many patients, leading to compromised performance status and organ function; other patient characteristics that frequently led to exclusion, including high tumor proliferative index or other pathologic features that were disallowed; and costs of routine diagnostic procedures often being borne by patients, which also contributed to pre-enrollment delays. Lessons from AMC-068 are being applied to the design and conduct of new AMC lymphoma trials in SSA, and the study has contributed to a strong operational foundation that will support innovative clinical trials in the future.

Evaluation of Foliar Diseases for Soybean Entries in the Pan-African Trials in Malawi and Zambia.

Soybean production has expanded worldwide including countries in sub-Saharan Africa. Several national and international agencies and research groups have partnered to improve overall performance of soybean breeding stocks and have introduced new germplasm from Brazil and the United States with the goal of developing new high-yielding cultivars. Part of this effort has been to test improved soybean lines/cultivars accumulated from private and public sources in multilocational trials in sub-Saharan Africa. These trials are known as the Pan-African Soybean Variety Trials, and the entries come from both private and public breeding programs. The objective of this research was to evaluate entries in the trials that include commercial cultivars or advanced experimental lines for the incidence and severity of foliar diseases. All trials were planted in December 2018 with six located in Zambia and one in Malawi. Plants were evaluated during the reproductive growth stages using a visual pretransformed severity rating scale. Foliar disease ratings were recorded for three bacterial diseases, six fungal diseases, one oomycete, and viruses. The overall occurrence of most of the diseases was high except for soybean rust and target spot, which were only found at two and one location, respectively. However, disease severity was generally low, although there were differences in disease severity ratings among the entries at some of the locations for brown spot, downy mildew, frogeye leaf spot, red leaf blotch, and soybean rust.

Healthcare-related stigma among men who have sex with men and transgender women in sub-Saharan Africa participating in HIV Prevention Trials Network (HPTN) 075 study

ABSTRACT The inability to access health services when needed is a critical barrier to HIV prevention, treatment and care among men who have sex with men (MSM) and transgender women (TGW). Using data collected in HPTN 075, we explored factors associated with any experienced healthcare-related stigma. HPTN 075 was a cohort study to assess the feasibility of recruiting and retaining MSM and TGW in clinical trials in sub-Saharan Africa. Of 401 MSM and TGW enrolled at four sites (Kisumu, Kenya; Blantyre, Malawi; Cape Town, Soweto, South Africa) 397 contributed to the analysis (79.9% cis-gender and 20.1% TGW). Of these, (45.3%; 180/397) reported one or more of healthcare-related stigma experiences. Most frequently reported experiences included fear to seek healthcare services (36.3%) and avoiding seeking such services because of the discovery of MSM status (29.2%). Few men and TGW (2.5%) reported having been denied health services because of having sex with men. In multivariable analysis, more participants in Soweto [adjusted odds ratio (AOR) = 2.60] and fewer participants in Blantyre (AOR = 0.27) reported any healthcare-related stigma experiences, in comparison to participants in Kisumu. MSM and TGW that did not have a supportive gay community to rely on were more likely to report any healthcare-related stigma experiences (AOR = 1.46), whereas MSM and TGW who reported high social support and who never had engaged in transactional sex were less likely to report such experiences (AOR = 0.76 and AOR = 0.43, respectively). Our results suggest that encouraging support groups for MSM and TGW as well as training and sensitizing healthcare staff, and the general community, on MSM and TGW health issues and cultural competence may reduce stigma, improve access to healthcare, which could ultimately reduce HIV transmission.