The early-stage comprehensive costs of routine PrEP implementation and scale-up in Zambia.

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention option, but cost-effectiveness is sensitive to implementation and program costs. Studies indicate that, in addition to direct delivery cost, PrEP provision requires substantial demand creation and client support to encourage PrEP initiation and persistence. We estimated the cost of providing PrEP in Zambia through different PrEP delivery models. Taking a guidelines-based approach for visits, labs and drugs, we estimated the annual cost of providing PrEP per client for five delivery models: one focused on key populations (men-who-have-sex-with-men (MSM) and female sex workers (FSW), one on adolescent girls and young women (AGYW), and three integrated programs (operated within HIV counselling and testing services at primary healthcare centres). Program start-up and support costs were based on program expenditure data and number of PrEP sites and clients in 2018. PrEP clinic visit costs were based on micro-costing at two PrEP delivery sites (2018 USD). Costs are presented in 2018 prices and inflated to 2021 prices. The annual cost/PrEP client varied by service delivery model, from $394 (AGYW) to $655 (integrated model). Cost differences were driven largely by client volume, which impacted the relative costs of program support and technical assistance assigned to each PrEP client. Direct service delivery costs ranged narrowly from $205-212/PrEP-client and were a key component in the cost of PrEP, representing 35-65% of total costs. The results show that, even when integrated into full service delivery models, accessing vulnerable, marginalised populations at substantial risk of HIV infection is likely to cost more than previously estimated due to the programmatic costs involved in community sensitization and client support. Improved data on individual client resource usage and outcomes is required to get a better understanding of the true resource utilization, expected outcomes and annual costs of different PrEP service delivery programs in Zambia.

Initial implementation of PrEP in Zambia: health policy development and service delivery scale-up.

INTRODUCTION: Daily pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but not yet widely deployed in sub-Saharan Africa. We describe how Zambia developed PrEP health policy and then successfully implemented national PrEP service delivery. POLICY DEVELOPMENT: Zambia introduced PrEP as a key strategy for HIV prevention in 2016, and established a National PrEP Task Force to lead policy advocacy and development. The Task Force was composed of government representatives, regulatory agencies, international donors, implementation partners and civil society organisations. Following an implementation pilot, PrEP was rolled out nationally using risk-based criteria alongside a national HIV prevention campaign. NATIONAL SCALE-UP: In the first year of implementation, ending September 2018, 3626 persons initiated PrEP. By September 2019, the number of people starting PrEP increased by over sixfold to 23 327 persons at 728 sites across all ten Zambian provinces. In the first 2 years, 26 953 clients initiated PrEP in Zambia, of whom 31% were from key and priority populations. Continuation remains low at 25% and 11% at 6 and 12 months, respectively. LESSONS LEARNT: Risk-based criteria for PrEP ensures access to those most in need of HIV prevention. Healthcare worker training in PrEP service delivery and health needs of key and priority populations is crucial. PrEP expansion into primary healthcare clinics and community education is required to reach full potential. Additional work is needed to understand and address low PrEP continuation. Finally, a task force of key stakeholders can rapidly develop and implement health policy, which may serve as a model for countries seeking to implement PrEP.

Case series of glans injuries during voluntary medical male circumcision for HIV prevention - eastern and southern Africa, 2015-2018.

BACKGROUND: Male circumcision confers partial protection against heterosexual HIV acquisition among men. The President's Emergency Plan for AIDS Relief (PEPFAR) has supported > 18,900,000 voluntary medical male circumcisions (VMMC). Glans injuries (GIs) are rare but devastating adverse events (AEs) that can occur during circumcision. To address this issue, PEPFAR has supported multiple interventions in the areas of surveillance, policy, education, training, supply chain, and AE management. METHODS: Since 2015, PEPFAR has conducted surveillance of GIs including rapid investigation by the in-country PEPFAR team. This information is collected on standardized forms, which were reviewed for this analysis. RESULTS: Thirty-six GIs were reported from 2015 to 2018; all patients were < 15 years old (~ 0·7 per 100,000 VMMCs in this age group) with a decreasing annual rate (2015: 0.7 per 100,000 VMMCs; 2018: 0.4 per 100,000 VMMC; p = 0.02). Most (64%) GIs were partial or complete amputations. All amputations among 10-14 year-olds occurred using the forceps-guided (FG) method, as opposed to the dorsal-slit (DS) method, and three GIs among infants occurred using a Mogen clamp. Of 19 attempted amputation repairs, reattached tissue was viable in four (21%) in the short term. In some cases, inadequate DS method training and being overworked, were found. CONCLUSION: Following numerous interventions by PEPFAR and other stakeholders, GIs are decreasing; however, they have not been eliminated and remain a challenge for the VMMC program. Preventing further cases of complete and partial amputation will likely require additional interventions that prevent use of the FG method in young patients and the Mogen clamp in infants. Improving management of GIs is critical to optimizing outcomes.

Novel metric for evaluating pre-exposure prophylaxis programme effectiveness in real-world settings.

Although large-scale provision of HIV pre-exposure prophylaxis (PrEP) is gaining momentum, no systematic method to evaluate or compare the effectiveness of different scale-up strategies in real-world settings exists. To date, estimating the effectiveness of PrEP has relied on clinical trials or mathematical models. We propose a novel and pragmatic metric to evaluate and compare programme effectiveness using routine implementation data. Using South African and Zambian PrEP guidelines, we provide two examples of how to consistently measure PrEP-programme effectiveness with routinely collected data. PrEP effectiveness should account for HIV seroconversion, the variable risk of HIV infection (seasons of risk) estimated with routine risk assessment at each clinic visit (when available), and the persistence of PrEP use. Three criteria should be met in order to be considered a successful outcome: first, a person who initiates PrEP must not seroconvert; second, there should be no more than one period at high risk of HIV infection during the follow-up period when not taking PrEP; and finally, an individual must continue to attend health-care visits or discontinue prophylaxis in consultation with a health-care provider within a specified follow-up period. The number of PrEP successes could then be compared with the total number of people initiating PrEP to establish a success ratio. This outcome is a useful and easily interpretable metric to monitor effectiveness of PrEP programmes with routinely collected clinical data and can be used in cost-effectiveness analyses. These measurements allow for comparisons of scale-up strategies for PrEP programmes and, if widely adopted, will allow comparative studies of different approaches for PrEP service delivery.

Increases in pediatric antiretroviral treatment, South Africa 2005-2010.

BACKGROUND: In South Africa in 2010, about 340,000 children under the age of 15 were infected with HIV. We describe the increase in the treatment of South African pediatric HIV-infected patients assisted by the President's Emergency Plan for AIDS Relief (PEPFAR) from 2004 to 2010. METHODS: We reviewed routine program data from PEPFAR-funded implementing partners among persons receiving antiretroviral treatment age 15 years old and less. Data quality was assessed during the reporting period by program officials through routine analysis of trends and logic checks. Based on UNAIDS estimated mortality rates of untreated HIV-infected children, we calculated the number of deaths averted and life-years gained in children under five receiving PEPFAR-assisted antiretroviral treatment. RESULTS: From October 2004 through September 2010, the number of children newly initiated on antiretroviral treatment in PEPFAR-assisted programs increased from 154 to 2,641 per month resulting in an increase from 2,412 children on antiretroviral treatment in September 2005 to 79,416 children in September 2010. Of those children who initiated antiretroviral treatment before September 2009, 0-4 year olds were 1.4 (95% CI: 1.3-1.5) times as likely to transfer out of the program or die as 5-14 year olds; males were 1.3 (95% CI: 1.0-1.7) times as likely to stop treatment as females. Approximately 27,548 years of life were added to children under-five years old from PEPFAR-assisted antiretroviral treatment. CONCLUSIONS: Pediatric antiretroviral treatment in South Africa has increased substantially. However, additional case-finding and a further acceleration in the implementation of pediatric care and treatment services is required to meet the current treatment need.

Supporting the massive scale-up of antiretroviral therapy: the evolution of PEPFAR-supported treatment facilities in South Africa, 2005-2009.

BACKGROUND: South Africa has an estimated 1.5 million persons in need of antiretroviral therapy (ART). In 2004, the South African government began collaborating with the United States President's Emergency Plan for AIDS Relief (PEPFAR) to increase access to ART. We determined how PEPFAR treatment support changed from 2005-2009. METHODS: In order to describe the change in number and type of PEPFAR-supported ART facilities, we analyzed routinely collected program-monitoring data from 2005-2009. The collected data included the number, type and province of facilities as well as the number of patients receiving ART at each facility. RESULTS: The number of PEPFAR-supported facilities providing ART increased from 184 facilities in 2005 to 1,469 facilities in 2009. From 2005-2009 the number of PEPFAR-supported government facilities increased 10.1 fold from 54 to 546 while the number of PEPFAR-supported NGO facilities (including general practitioner and NGO facilities) increased 6.2 fold from 114 to 708. In 2009 the total number of persons treated at PEPFAR-supported NGO facilities was 43,577 versus 501,089 persons at PEPFAR-supported government facilities. Overall, the median number of patients receiving ART per site increased from 81 in 2005 to 136 in 2009. CONCLUSIONS: To mitigate the gap between those needing and those receiving ART, more facilities were supported. The proportion of government facilities supported and the median number of persons treated at these facilities increased. This shift could potentially be sustainable as government sites reach more individuals and receive government funding. These results demonstrate that PEPFAR was able to support a massive scale-up of ART services in a short period of time.

Scale-up and continuation of antiretroviral therapy in South African treatment programs, 2005-2009.

BACKGROUND: South Africa has the greatest burden of HIV-infection in the world with about 5.2 million HIV-infected adults. In 2003, the South African Government launched a comprehensive HIV and AIDS care treatment program supported by the United States in 2004 through the President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: To describe the scale-up and continuation of antiretroviral therapy in South African Government and PEPFAR-supported sites in South Africa, we conducted a retrospective analysis of routinely collected program reporting data, 2005-2009. RESULTS: From 2005 through 2009, the average rate of persons initiated on antiretroviral therapy in PEPFAR-supported South African Government treatment programs increased nearly four-fold from 6,327 a month in 2005-2006 to 24,622 a month in 2008-2009 resulting in an increase from 33,543 patients on continued treatment in April-June 2005 to 631,985 patients in July-September 2009. Of those 631,985 patients receiving treatment, 65% were women. Men were more likely to be lost to follow-up (9.2% vs. 7.8%, PR 1.18, 95% CI 1.17-1.19) and more likely to die (5.6% vs. 4.1%, PR 1.36, 95% CI 1.35-1.37) than women. CONCLUSIONS: Scale-up and continuation of antiretroviral therapy in South Africa has been a remarkable medical accomplishment. Because more women receive and continue treatment, more efforts are needed to treat and retain men.

The associations of voluntary counseling and testing acceptance and the perceived likelihood of being HIV-infected among men with multiple sex partners in a South African township.

This paper examines the socio-demographic factors and sexual risk behaviors (condom use, number of sexual partners, STI symptoms) associated with voluntary counselling and testing (VCT) acceptance and self-perceived risk of being HIV-infected among black men with multiple and younger sex partners in a South African township outside of Cape Town. Using respondent driven sampling, we interviewed 421 men, of whom 409 (97.3%) consented to provide a dried blood spot, 12.3% were HIVinfected (95% confidence intervals [CI.] 8.3, 16.9) and 47.2% (CI. 41.1, 53.6) accepted on site VCT. Twenty six percent (CI. 20.2, 30.7) reported having an HIV test in the past year. Few men perceived themselves as very likely to be infected with HIV (15.6%; CI. 10.4, 20.5). VCT acceptance was significantly associated with being older, married or living with a partner, having higher education, having four to six partners in the past three months and testing HIV positive. Self-perceived likelihood of being HIV infected was significantly associated with low condom use and having seven or more partners in the past three months, and testing HIV positive. These findings indicate that men correctly understand that engaging in certain HIV risk behaviors increases the likelihood of HIV-infection. However, those who perceive themselves at high risk of having HIV do not seek testing. Further investigation into the psychological and cultural barriers to reducing risky sexual behaviors and accessing VCT and other HIV services is recommended.

Estimating HIV prevalence and risk behaviors among high-risk heterosexual men with multiple sex partners: use of respondent-driven sampling.

OBJECTIVES: To collect HIV data from high-risk men who have multiple, younger, female sex partners in a periurban township in South Africa. DESIGN: Unlinked anonymous cross-sectional survey using respondent-driven sampling. METHODS: Survey conducted among men aged 18 years or older who reported having had sex with more than 1 female partner in the previous 3 months (one of whom was either 3 or more years younger than the participant or below the age of 24) and lived in the area of recruitment. RESULTS: The median age of the 421 recruited men was 28 years (range: 18-62 years). They reported a median of 6 sexual partners (range: 2-39) during the past 3 months, and 51% (confidence interval: 45.0 to 59.6) reported inconsistent condom use with their casual partners. During the 3 months before the survey, 98% of men reported having concurrent sexual relationships. HIV prevalence was 12.3% (confidence interval: 8.3% to 16.9%). Being older than 24 years and not using a condom during the last sexual intercourse with a 1-time sexual partner were significantly associated with HIV infection. CONCLUSIONS: This group of heterosexual urban men practice high levels of risky sexual behavior and are an important group that require more targeted HIV surveillance and prevention interventions.