Assessing the efficacy of an integrated intervention to create demand for fishermen’s schistosomiasis and HIV services (FISH) in Mangochi, Malawi: Study protocol for a cluster randomized control trial

Background Both HIV and schistosomiasis are major public health problems worldwide with 1.8 million new HIV infections, and up to 110 million untreated schistosomiasis cases globally. Although a causal link has not been established, there are strong suggestions that having schistosomiasis increases onward transmission of HIV from co-infected men to women. With both HIV and schistosomiasis treatment readily available in Malawi, there is a need to investigate the feasibility, acceptability and health impacts of joint management of these two hazards, with special focus on health education and demand-creation for fishermen. The aim of this project is to identify optimal models of delivering integrated HIV and schistosomiasis services for fishermen, particularly investigating the effect of using social networks, HIV self-test kits and beach clinic services in Mangochi, Malawi. Methods We have mapped 45 boat teams or landing sites for a 3-arm cluster randomized trial using “boat team” as the unit of randomization. The three arms are: 1) Standard of care (SOC) with leaflets explaining the importance of receiving presumptive treatment for schistosomiasis (praziquantel) and HIV services for fishermen, and two intervention arms of 2) SOC + a peer explaining the leaflet to his fellow fishermen in a boat team; and 3) arm 2 with HIV self-test kits delivered to the boat team fishermen by the peer. The primary outcomes measured at 9 months of trial delivery will compare differences between arms in the proportions of boat-team fishermen: 1) who self-report starting antiretroviral therapy or undergoing voluntary medical male circumcision; and 2) who have ≥1 S. haematobium egg seen on light microscopy of the filtrate from 10mls urine (“egg-positive”). Discussion This is the first evaluation of an integrated HIV and schistosomiasis services intervention for fishermen, particularly investigating the effect of using social networks, HIVST kits and beach clinic services. The findings will support future efforts to integrate HIVST with other health services for fishermen in similar settings if found to be efficacious. Trial registration This trial is registered in the ISRCTN registry: ISRCTN14354324; date of registration: 05 October 2020. https://www.isrctn.com/ISRCTN14354324?q=ISRCTN14354324&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search. Linked to protocol version number 1.4 of 11 January 2021.

The risks and benefits of providing HIV services during the COVID-19 pandemic

Introduction The COVID-19 pandemic has caused widespread disruptions including to health services. In the early response to the pandemic many countries restricted population movements and some health services were suspended or limited. In late 2020 and early 2021 some countries re-imposed restrictions. Health authorities need to balance the potential harms of additional SARS-CoV-2 transmission due to contacts associated with health services against the benefits of those services, including fewer new HIV infections and deaths. This paper examines these trade-offs for select HIV services. Methods We used four HIV simulation models (Goals, HIV Synthesis, Optima HIV and EMOD) to estimate the benefits of continuing HIV services in terms of fewer new HIV infections and deaths. We used three COVID-19 transmission models (Covasim, Cooper/Smith and a simple contact model) to estimate the additional deaths due to SARS-CoV-2 transmission among health workers and clients. We examined four HIV services: voluntary medical male circumcision, HIV diagnostic testing, viral load testing and programs to prevent mother-to-child transmission. We compared COVID-19 deaths in 2020 and 2021 with HIV deaths occurring now and over the next 50 years discounted to present value. The models were applied to countries with a range of HIV and COVID-19 epidemics. Results Maintaining these HIV services could lead to additional COVID-19 deaths of 0.002 to 0.15 per 10,000 clients. HIV-related deaths averted are estimated to be much larger, 19–146 discounted deaths per 10,000 clients. Discussion While there is some additional short-term risk of SARS-CoV-2 transmission associated with providing HIV services, the risk of additional COVID-19 deaths is at least 100 times less than the HIV deaths averted by those services. Ministries of Health need to take into account many factors in deciding when and how to offer essential health services during the COVID-19 pandemic. This work shows that the benefits of continuing key HIV services are far larger than the risks of additional SARS-CoV-2 transmission.

Characterizing health care provider knowledge: Evidence from HIV services in Kenya, Rwanda, South Africa, and Zambia

Background Identifying approaches to improve levels of health care provider knowledge in resource-poor settings is critical. We assessed level of provider knowledge for HIV testing and counseling (HTC), prevention of mother-to-child transmission (PMTCT), and voluntary medical male circumcision (VMMC). We also explored the association between HTC, PMTCT, and VMMC provider knowledge and provider and facility characteristics. Methods We used data collected in 2012 and 2013. Vignettes were administered to physicians, nurses, and counselors in facilities in Kenya (66), Rwanda (67), South Africa (57), and Zambia (58). The analytic sample consisted of providers of HTC (755), PMTCT (709), and VMMC (332). HTC, PMTCT, and VMMC provider knowledge scores were constructed using item response theory (IRT). We used GLM regressions to examine associations between provider knowledge and provider and facility characteristics focusing on average patient load, provider years in position, provider working in another facility, senior staff in facility, program age, proportion of intervention exclusive staff, person-days of training in facility, and management score. We estimated three models: Model 1 estimated standard errors without clustering, Model 2 estimated robust standard errors, and Model 3 estimated standard errors clustering by facility. Results The mean knowledge score was 36 for all three interventions. In Model 1, we found that provider knowledge scores were higher among providers in facilities with senior staff and among providers in facilities with higher proportions of intervention exclusive staff. We also found negative relationships between the outcome and provider years in position, average program age, provider working in another facility, person-days of training, and management score. In Model 3, only the coefficients for provider years in position, average program age, and management score remained statistically significant at conventional levels. Conclusions HTC, PMTCT, and VMMC provider knowledge was low in Kenya, Rwanda, South Africa, and Zambia. Our study suggests that unobservable organizational factors may facilitate communication, learning, and knowledge. On the one hand, our study shows that the presence of senior staff and staff dedication may enable knowledge acquisition. On the other hand, our study provides a note of caution on the potential knowledge depreciation correlated with the time staff spend in a position and program age.

The development of an explanatory model for voluntary medical male circumcision in KwaZulu-Natal, South Africa

Background: KwaZulu-Natal (KZN) remains the epicentre of the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in South Africa. The incidence of HIV infection in KZN necessitates cost-effective strategies to curb the spread of infection. Voluntary medical male circumcision (VMMC) has been adopted as an additional biomedical preventive strategy since 2010 in line with recommendations from the World Health Organization. Despite several attempts to scale-up VMMC to reach age specific targets to achieve immediate aversion of infections, the uptake of VMMC remains sub-optimal, particularly in KZN. The purpose of this study is to describe the processes that were followed in developing, describing and evaluating an explanatory model for VMMC in KZN, South Africa.Methods: A qualitative theory-generative phenomenographic study design was used to analyse the qualitative differences in primary healthcare stakeholders’ experiences, understanding and conceptions of VMMC in KZN, South Africa. The emerging results informed the development of the VMMC explanatory model for KZN, South Africa. The model development process followed four steps, namely (1) concept analysis, (2) construction of relational statements, (3) model description and (4) model evaluation. The criteria of relevance for the target audience – applicability, clarity, user friendliness and originality of work – were used to evaluate the model.Results: The model’s central premise is that the decision to undergo VMMC is shaped by a complex interplay of factors in the context or external environment of males (the extrinsic variable), which influences specific experiences, conceptions and understanding regarding VMMC (the influential/intrinsic variables). These collectively determine men’s responses to VMMC (the outcome variable).Conclusion: The model describes the process by which contextual, extrinsic and intrinsic variables interact to determine an individual male’s response to VMMC, thus providing a guide to primary healthcare providers on care, practice and policy interventions to support the uptake of VMMC in the rural primary healthcare context of KZN, South Africa.

Urethrocutaneous Fistula Following VMMC: A Case Series from March 2013 to October 2019 in ZAZIC’s Voluntary Medical Male Circumcision Program in Zimbabwe

Background: Urethrocutaneous fistula (subsequently, fistula) is a rare adverse event (AE) in voluntary medical male circumcision (VMMC) programs. Global fistula rates of 0.19 and 0.28 per 100,000 VMMCs were reported. Management of fistula can be complex and requires expert management. We describe seven cases of fistula in our large-scale VMMC program in Zimbabwe. We present fistula rates; provide an overview of initial management, surgical interventions, and patient outcomes; discuss causes; and suggest future prevention efforts. Results: Case details are presented on fistulas identified between March 2013 and October 2019. Among the seven fistula clients, ages ranged from 10-22 years; 6 cases were among boys under 15 years of age. All clients received surgical VMMC by trained providers in an outreach setting. Clients presented with fistulae 2 to 42 days after VMMC. Secondary infection was identified in 6 of 7 cases. Six cases were managed through surgical repair. The number of repair attempts ranged from 1 to 10. One case healed spontaneously with conservative management. Fistula rates are presented as cases/100,000 VMMCs.Conclusion: Fistula is an uncommon but severe AE that requires clinical expertise for successful management and repair. High-quality AE surveillance should identify fistula promptly and include consultation with experienced urologists. Strengthening provider surgical skills and establishment of standard protocols for fistula management would aid future prevention efforts in VMMC programs.

Prevalence and correlates of voluntary medical male circumcision adverse events among adult males in the Copperbelt Province of Zambia: A cross-sectional study

Background Voluntary Medical Male Circumcision (VMMC) is a key intervention in HIV/AIDS. Improving VMMC program uptake in Zambia requires careful monitoring of adverse events (AE) to inform program quality and safety. We investigate the prevalence of VMMC AE and their associated factors among adult males in Ndola, Copperbelt Province, Zambia. Methods We performed a cross-sectional study using secondary clinical data collected in 2015 using two validated World Health Organisation/Ministry of Health reporting forms. We reviewed demographics and VMMC surgical details from 391 randomly sampled adult males aged ≥18 years at Ndola Teaching Hospital, a specialised VMMC fixed site in Zambia. Non-parametric tests (Fisher’s exact test or Chi-square depending on assumptions being met) and logistic regression were conducted to determine the relationships between associated factors and VMMC AE. Results The overall VMMC AE prevalence was 3.1% (95% CI 1.60%– 5.30%) and most AEs occurred postoperatively. In decreasing order, the commonly reported VMMC AE included; bleeding (47.1%), swelling (29.4%), haematoma (17.6%), and delayed wound healing (5.9%). There was an inversely proportional relationship between VMMC volume (as measured by the number of surgeries conducted per VMMC provider) and AEs. Compared to the highest VMMC volume of 63.2% (247/391) as reference, as VMMC volume reduced to 35.0% (137/391) and then 1.8% (7/391), the likelihood of AEs increased by five times (aOR 5.08; 95% CI 1.33–19.49; p = 0.018) and then sixteen times (aOR 16.13; 95% CI 1.42–183.30; p = 0.025) respectively. Conclusions Our study found a low prevalence of VMMC AEs in Ndola city, Copperbelt Province of Zambia guaranteeing the safety of the VMMC program. We recommend more surgically proficient staff to continue rendering this service. There is a need to explore other high priority national/regional areas of VMMC program safety/quality, such as adherence to follow-up visits.

Development of a women empowerment framework to promote voluntary medical male circumcision uptake for HIV prevention in Zimbabwe

ABSTRACT Introduction: This study aimed to develop a women empowerment framework to promote Voluntary Medical Male Circumcision (VMMC) uptake for human immune-deficiency virus (HIV) prevention, guided by the following objectives: To explore relevant literature on the role of women in promoting male circumcision uptake; To develop a women empowerment framework to promote male circumcision uptake; To describe the women empowerment framework to promote male circumcision uptake. Methods: The study used a theory-generation design to explore, describe and develop a women empowerment framework from a broad literature review. Results: A three-phase approach suitable for the framework development emerged from the literature review. Phase one involved exploring relevant literature on role of women in male circumcision uptake, using the Population/problem, Intervention, Comparison and Outcome (PICO) method to identify and define the key concepts. Phase 2 adopted and adapted Maibvise and Mavundla model in identifying the following concepts: change agents as the health care providers, recipients as the women to influence men eligible for male circumcision, promoting male circumcision uptake and success of the male circumcision program. Phase 3 provided a detailed description of the framework including three key steps of empowerment of women, influencing positive perceptions of men and utilisation of male circumcision services. Conclusions: The identified concepts resulted in development of a women empowerment framework, which can be used as an education and advocacy tool in building the capacity of women in supporting the male circumcision programme to promote uptake. Further research is required to expand the utilisation of the framework in male circumcision healthcare services. KEY WORDS: Women empowerment, framework, voluntary medical male circumcision, male circumcision uptake, HIV prevention