Pilot studies, a subset of feasibility studies, are essential in determining the feasibility of a larger study. This is especially true when targeting populations that are difficult to recruit, such as people with HIV. Designing high quality pilot studies can help limit waste by informing researchers how to proceed. We conducted a meta-epidemiological review of pilot studies in the HIV literature published until November 25, 2020 using Medline, Embase and Cochrane Controlled Register of Trials (CENTRAL). We extracted bibliometric information, including the region and income of the country where the study was conducted, study design, using the pilot label, source of funding, nature of intervention, whether feasibility was the primary objective, progression criteria, protocol registration and sample size estimation. We used descriptive analysis to evaluate how pilot studies are designed and conducted, the outcomes assessed and how are they defined. Our search retrieved 10,597 studies, of which 248 were included in our final review. The number of pilot studies has increased with time, with 25, 55, and 44 HIV studies published in 2018, 2019, and 2020, respectively. We found that 128 studies (70.39%) used the pilot or feasibility labels in their title, however 20.31% used these titles interchangeably. 5 studies in this review included progression criteria, all of which were published in 2020. Sample size estimation was only found in 59 studies (23.9%). Pilot studies in the HIV literature are mislabeled. Sample size estimations are seldom included, and progression criteria are used. Formal guidance on the design and reporting of pilot studies in the HIV literature is necessary. / Thesis / Master of Science (MSc) / Pilot studies are important in evaluating whether planned larger studies can be conducted. They are particularly useful in the field of HIV where participants may be hard to identify and recruit. However, there are few instructions on how pilot studies in HIV should be designed. We searched the literature to see the current state of HIV pilot studies, including how they are designed, and their findings reported. We found that pilot studies are becoming more popular in the HIV field. However, there were gaps in how these studies are designed and reported. Studies were often mislabeled as pilots when they were not, the pilot study criteria were applied inconsistently and the outcomes that were evaluated were often poorly defined and their information poorly presented. Pilot studies in HIV can be reported better.

Master of Public Health - MPH / Background: HIV/AIDS remains a major public health issue that is affecting all population groups and communities in Zambia. Among the most affected groups are key populations (KPs) such as female sex workers. KPs are considered at high risk of contracting HIV but have limited access to HIV services and retention in care due to internalized stigma, discrimination, criminalization, and negative attitudes towards HIV treatment. Under the USAID Open Doors project in Zambia, KPs access comprehensive HIV prevention, care and treatment services. The test and treat strategy is implemented by the project in support of the UNAIDS 90-90-90 targets by 2020 to diagnose 90% of people living with HIV, put 90% of them on treatment, and for 90% of them to have suppressed viral load. Aim: This study aimed to determine retention in care among female sex workers (FSWs) in the first six months after ART initiation using the HIV care cascade. Methodology: A retrospective cohort study was conducted of all new HIV positive female sex workers (FSWs) initiated on ART between October 2018 and June 2019 (9 months period) based on the electronic records. Data were extracted from SmartCare, an electronic health record system used by the ART clinic. Microsoft Excel and Epi-Info 7 software were used for data entry and analysis. Kaplan–Meier survival analysis was conducted to examine differences in retention rates. Results: A total of 205 FSWs were initiated on ART, out of which 180 were active on ART (36 youths and 144 adults) and 25 were lost to follow-up (four youths and 21 adults) during the 9 months study period. Of the 180 FSWs active on ART, 36 were FSWs aged 18 – 24 years (youths) representing 90% retained in care while 144 were FSWs aged 25 – 42 years (adults) with 87% being retained on ART treatment. Retention in ART care was not significantly different in the survival curves between the age groups of FSW youths and FSW adults during the study period (p-value = 0.637). Retention in ART care was not statistically significant for education (p-value = 0.481), marital status (p-value = 0.545), and occupation (p-value = 0.169). Conclusion: Retention in ART care among FSWs was 88%. However, there were no significant differences by age group identified in this study. While this study shows 88% retention rate among FSWs, it will be used as a baseline in meeting the UNAIDS 90-90-90 goals.

Magister Public Health - MPH / Background: HIV/AIDS remains a major public health issue that is affecting all population groups and communities in Zambia. Among the most affected groups are key populations (KPs) such as female sex workers. KPs are considered at high risk of contracting HIV but have limited access to HIV services and retention in care due to internalized stigma, discrimination, criminalization, and negative attitudes towards HIV treatment. Under the USAID Open Doors project in Zambia, KPs access comprehensive HIV prevention, care and treatment services. The test and treat strategy is implemented by the project in support of the UNAIDS 90-90-90 targets by 2020 to diagnose 90% of people living with HIV, put 90% of them on treatment, and for 90% of them to have suppressed viral load. Aim: This study aimed to determine retention in care among female sex workers (FSWs) in the first six months after ART initiation using the HIV care cascade. Methodology: A retrospective cohort study was conducted of all new HIV positive female sex workers (FSWs) initiated on ART between October 2018 and June 2019 (9 months period) based on the electronic records. Data were extracted from SmartCare, an electronic health record system used by the ART clinic. Microsoft Excel and Epi-Info 7 software were used for data entry and analysis. Kaplan–Meier survival analysis was conducted to examine differences in retention rates. Results: A total of 205 FSWs were initiated on ART, out of which 180 were active on ART (36 youths and 144 adults) and 25 were lost to follow-up (four youths and 21 adults) during the 9 months study period. Of the 180 FSWs active on ART, 36 were FSWs aged 18 – 24 years (youths) representing 90% retained in care while 144 were FSWs aged 25 – 42 years (adults) with 87% being retained on ART treatment. Retention in ART care was not significantly different in the survival curves between the age groups of FSW youths and FSW adults during the study period (p-value = 0.637). Retention in ART care was not statistically significant for education (p-value = 0.481), marital status (p-value = 0.545), and occupation (p-value = 0.169). Conclusion: Retention in ART care among FSWs was 88%. However, there were no significant differences by age group identified in this study. While this study shows 88% retention rate among FSWs, it will be used as a baseline in meeting the UNAIDS 90-90-90 goals.

Background Female Sex Workers (FSW) in Mali are highly vulnerable to HIV. Their prevalence in 2009 was nine times higher (24.2%) than that among pregnant women (2.7%). The aim of this study was to document the effectiveness of HIV prevention programming targeting FSW between 2000 and 2013 funded by the U.S. Government (USG) in Mali. Methods The content, scope and coverage of interventions were assessed through a document review and key informant interviews with FSW peer educators and program managers. Data from the Integrated Sexually Transmitted Infection (STI) Prevalence and Behavior Surveys (ISBS) conducted in 2000, 2003, 2006, and 2009 were analyzed to measure changes in outcomes over time. Multivariate logistic regression was used to control for changes in FSW demographics and to analyze sub-groups. Results From 2000 to 2013 the USG was the key partner to the government of Mali (GOM) for HIV testing, surveillance, STI treatment, and behavior change communication (BCC) targeting FSW. The USG spent over $42 million on HIV programming between 2003 and 2013. Since 2001, programming for FSW covered most urban areas and transport hubs in Mali. USG partners exceeded their goals, making over 1.3 million BCC contacts with FSW and their sexual partners. However, outcomes were negatively impacted by frequent stock-outs of medications to treat STIs between 2006 and 2011. Also, evidence suggests that interventions were of insufficient intensity and coverage. Finally, M&E system was rudimentary and inconsistent, which made it impossible to link outcomes with programming with confidence. Nevertheless, important positive changes in outcomes occurred. Between 2003 and 2009, HIV prevalence dropped from 44.14% to 28.49% (P <0.0001) among Malian FSW, from 21.33% to 12.71% (P =0.0082) among Nigerian FSW, and from 43.42% to 33.67% (P =0.0442) among FSW from other countries. Between 2000 and 2009 HIV testing increased (40% to 76% P <0.0001). Consistent condom use with clients improved for Malian FSW (72.3% to 81.5% P =0.0092). Consistent condom use with boyfriends was low and improved only for Nigerian FSW (9.8% to 28.4% P =0.0003). Factors associated with HIV prevalence in the multivariate model were older age, study year (2003 and 2006), nationality, lack of education, mobility, STI symptoms, gonorrhea prevalence, and younger age at first sex. Conclusions This study documents progress in the fight against HIV among FSW in Mali, but coverage and intensity must be increased and the quality and diversity of interventions must be expanded. The different vulnerabilities to HIV of different nationality FSW should be addressed in future programming and research. Program adoption of and adherence to Mali’s new M&E plan for key populations would do much to facilitate the necessary improvements. / 2017-04-02T00:00:00Z