Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda.

The COVID-19 pandemic threatens the food security of people in low-income countries. This is important for people living with HIV (PLWH) because HIV medication should be taken with food to avoid side-effects. We used survey data (n = 314) and qualitative interviews (n = 95) to longitudinally explore how the pandemic impacted food insecurity among PLWH in Kampala, Uganda. Prior to March 2020, 19.7% of respondents were food insecure. Our regression models estimate that food insecurity rose by 9.1 percentage points in our first round of surveys (June-September 2020; p < 0.05; t = 2.17), increasing to 17.2 percentage points in the second round of surveys (July-November 2021; p < 0.05; t = 2.32). Qualitative interviews reveal that employment loss and deteriorating support systems led to reduced meals and purchasing of cheaper foods. Respondents reported continuing to take their HIV medication even in the presence of food insecurity. Strategies for ensuring that PLWH have enough food should be prioritized so that the millions of PLWH in sub-Saharan Africa can take their medication without experiencing uncomfortable side-effects.Clinical Trials Registration Number NCT03494777.

Correlates of Undiagnosed HIV Infection and Retesting Among Voluntary HIV Testing Clients at Mildmay Clinic, Uganda.

Increasing HIV diagnosis is important for combatting HIV. We invited individuals aged ≥ 13 years seeking voluntary HIV testing at Mildmay Clinic in Uganda to undertake a computer or audio-computer-assisted self-interview to facilitate post-test counseling. We evaluated first-visit data from 12,233 consenting individuals between January 2011 and October 2013. HIV prevalence was 39.0%. Of those with HIV, 37.2% already knew they were infected. Undiagnosed infection was associated with not being single, screening positive for depression (aOR 1.16, 95% CI 1.04-1.28), and screening for harmful drinking behavior (aOR 1.23, 95% CI 1.10-1.39). The odds of retesting subsequent to HIV diagnosis were lower for males (aOR 0.80, 95% CI 0.70-0.92) and those screening positive for harmful drinking behavior (aOR 0.77, 95% CI 0.66-0.88). Retesting was also associated with higher education and perceived social status below 'better off'. Our findings reiterate the value of population-based HIV surveys to provide estimates of testing coverage.

Motivations and barriers to cervical cancer screening among HIV infected women in HIV care: a qualitative study.

BACKGROUND: Cervical cancer is the second commonest cancer in women worldwide and the commonest cancer among women in Uganda. Annual cervical screening is recommended for women living with HIV for early detection of abnormal cervical changes, however uptake remains grossly limited. This study assessed factors associated with cervical screening uptake among HIV infected women at Mildmay Uganda where cervical screening using Visual inspection with acetic acid and iodine (VIA and VILI) was integrated into HIV care since July 2009. METHODS: Eighteen (18) in-depth interviews with HIV infected women and 6 key informant interviews with health care providers were conducted in April 2013 to assess client, health care provider and facility-related factors that affect cervical screening uptake. In-depth interview respondents included six HIV infected women in each of the following categories; women who had never screened, those who had screened once and missed follow-up annual screening, and those who had fully adhered to the annual screening schedule. Data was analyzed using content analysis method. RESULTS: Motivations for cervical cancer screening included the need for comprehensive assessment, diagnosis, and management of all ailments to ensure good health, fear of consequences of cervical cancer, suspicion of being at risk and the desire to maintain a good relationship with health care workers. The following factors negatively impacted on uptake of cervical screening: Myths and misconceptions such as the belief that a woman's ovaries and uterus could be removed during screening, fear of pain associated with cervical screening, fear of undressing and the need for women to preserve their privacy, low perceived cervical cancer risk, shortage of health workers to routinely provide cervical cancer education and screening, and competing priorities for both provider and patient time. Major barriers to repeat screening included limited knowledge and appreciation of the need for repeat screening, and lack of reminders. CONCLUSIONS: These findings highlight the need for client-centered counseling and support to overcome fears and misconceptions, and to innovatively address the human resource barriers to uptake of cervical cancer screening among HIV infected women.

INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda.

INTRODUCTION: Habits are a common strategy for successfully countering medication non-adherence, yet existing interventions do not support participants during the long habit formation period, resulting in high attrition. We test a novel intervention combining text messages and incentives with anchoring to support antiretroviral therapy (ART) pill-taking habits. METHODS: In a randomized, parallel controlled trial, a sample of 155 participants 18 years and older who initiated ART within 3 months were recruited at Mildmay Uganda between October 2021 and April 2022. All participants were educated on the anchoring strategy and chose an anchor, that is existing routines, to pair with pill-taking. Participants were randomized to either usual care (C = 49), daily text message reminders to follow their anchoring plan (Messages group; T1 = 49) or messages and incentives conditional on pill-taking in line with their anchor (Incentives group; T2 = 57). Assessments occurred at baseline, month 3 (end of intervention) and month 9 (end of observation period). The primary outcomes are electronically measured mean adherence and pill-taking consistent with participants' anchor time. RESULTS: The primary outcome of pill-taking in line with the anchoring plan was higher in the Incentives group during the 3-month intervention (12.2 p.p. [95% CI: 2.2 22.2; p = .02]), and remained significantly higher after the incentives were withdrawn (months 4-6 (14.2 p.p. [95% CI 1.1 27.2; p = .03]); months 7-9 (14.1 p.p. [95% CI -0.2 28.5; p = .05])). Mean adherence was higher in both treatment groups relative to the control group during the intervention (T1 vs. C, p = .06; T2 vs. C, p = .06) but not post-intervention. CONCLUSIONS: The promising approach of using incentives to support habit formation among ART treatment initiators needs to be evaluated in a fully powered study to further our understanding of the habit formation process and to evaluate its cost-effectiveness.

Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda.

BACKGROUND: This study tests behavioral economics incentives to improve adherence to antiretroviral treatment (ART), with 1 approach being low cost. SETTING: Three hundred twenty-nine adults at Mildmay Hospital in Kampala, Uganda, on ART for at least 2 years and showing adherence problems received the intervention for about 15 months until the study was interrupted by a nation-wide COVID-19 lockdown. METHODS: We randomized participants into 1 of 3 (1:1:1) groups: usual care ("control" group; n = 109) or 1 of 2 intervention groups where eligibility for nonmonetary prizes was based on showing at least 90% electronically measured ART adherence ("adherence-linked" group, n = 111) or keeping clinic appointments as scheduled ("clinic-linked"; n = 109). After 12 months, participants could win a larger prize for consistently high adherence or viral suppression. Primary outcomes were mean adherence and viral suppression. Analysis was by intention-to-treat using linear regression. This trial is registered with ClinicalTrials.gov, NCT03494777 . RESULTS: Neither incentive arm increased adherence compared with the control; we estimate a 3.9 percentage point increase in "adherence-linked" arm [95% confidence interval (CI): -0.70 to 8.60 ( P = 0.10)] and 0.024 in the "clinic-linked" arm [95% CI: -0.02 to 0.07 ( P = 0.28)]. For the prespecified subgroup of those with initial low adherence, incentives increased adherence by 7.60 percentage points (95% CI: 0.01, 0.15; P = 0.04, "adherence-linked") and 5.60 percentage points (95% CI: -0.01, 0.12; P = 0.10, "clinic-linked"). We find no effects on clinic attendance or viral suppression. CONCLUSIONS: Incentives did not improve viral suppression or ART adherence overall but worked for the prespecified subgroup of those with initial low adherence. More effectively identifying those in need of adherence support will allow better targeting of this and other incentive interventions.

Recommendations for Improving Oral Pre-exposure Prophylaxis Implementation and Social Marketing in Ugandan Fisherfolk Communities: A Qualitative Exploration.

Background: HIV is hyperendemic among fisherfolk in Sub-Saharan Africa, especially around Lake Victoria, Uganda. Purpose/Research Design: We conducted cross-sectional semi-structured interviews about oral pre-exposure prophylaxis (PrEP) implementation with 35 Ugandan fisherfolk (15 women, 20 men) and 10 key stakeholders (healthcare providers, policymakers, community leaders). We used a directed content analysis approach based on implementation science and social marketing frameworks. Results: Participants showed high acceptability for PrEP. Anticipated barriers among fisherfolk included stigma (due to similar medications/packaging as HIV treatment); misconceptions; mobility, competing needs, poverty, and partner conflict. Anticipated provider barriers included insufficient staffing and travel support. Recommendations included: change PrEP packaging; integrate PrEP with other services; decrease PrEP refill frequency; give transportation resources to providers; train more healthcare workers to provide PrEP to fisherfolk; and use positively framed messages to promote PrEP. Conclusions: Results can inform policymakers and healthcare organizations on how to overcome barriers to PrEP scale-up in most at-risk populations with poor healthcare access.

Barriers and facilitators of antiretroviral therapy (ART) adherence habit formation in Sub-Saharan Africa: Evidence from a qualitative study in Kampala, Uganda.

RATIONALE: In 2020, nearly 40 million people lived with HIV/AIDS (PLWHA) worldwide, of whom 70% were receiving antiretroviral therapy (ART). Two-thirds of PLWHA reside in Sub-Saharan Africa (SSA), where rates of viral load suppression are often suboptimal and frequently attributed to low ART adherence. Strong pill-taking habits are often reported as a key strategy among those who successfully maintain medication adherence, yet not enough is known about the barriers and facilitators in SSA to pill-taking in response to the same contextual cue, which is a necessary step in the habit formation process. OBJECTIVE: To address this knowledge gap and to inform a subsequent intervention to promote context-dependent repetition, called anchoring, we used a formative qualitative approach to collect in-depth narratives about barriers and facilitators of the anchoring intervention for establishing ART pill-taking habits at the Mildmay Hospital in Kampala, Uganda. METHODS: We conducted interviews with 25 randomly selected patients starting ART, 5 expert patients, and 10 providers at Mildmay, and performed a rapid analysis to inform the intervention in a timely manner. RESULTS: We found that pill taking in response to the same contextual cue, or anchor, was threatened by stigma and food insecurity and that the COVID-19 pandemic exacerbated these barriers. We also determined that important linguistic changes were needed to the instructional materials and reminder messages in the subsequent intervention to avoid words and phrases with negative connotations for this target population. CONCLUSIONS: Several important barriers and facilitators to context-dependent pill taking in Uganda were identified through our formative research that helped to inform important revisions to our subsequent intervention. These findings underscore the importance of understanding local barriers and facilitators when designing and planning interventions, particularly when implementing theory-based intervention approaches that have yet to be tested in a new setting.

Goals for Adherence with Low-cost Incentives (GOALS): a protocol for a randomized controlled trial evaluating the impact of small airtime incentives on ART adherence among young people living with HIV in Kampala, Uganda.

BACKGROUND: Treatment outcomes of HIV-positive individuals are threatened by low antiretroviral therapy (ART) adherence, a problem that is particularly acute among youth. Incentives are a promising tool to support ART adherence, but traditional incentive designs rewarding uniformly high levels of the desired health behavior may demotivate those with low levels of the behavior. In this study, we investigate the effectiveness of alternative approaches to target-setting for incentive eligibility using subgoals (i.e., individual-specific, interim targets leading up to the optimal target). METHODS / DESIGN: We will enroll 628 HIV-positive youth between ages 15 and 30 into a 3-year randomized controlled trial. Participants will be randomized 1:1:1:1 to a control arm or one of three intervention arms (n = 157 each) that allow them to enter a prize drawing for small incentives if their ART adherence meets the given goal. In the first arm (T1, assigned subgoal), goals will be externally assigned and adapted to their initial adherence level. In the second arm (T2, participatory subgoal), participants can set their own interim goals. In the third arm (T3, fixed goal), all participants must reach the same target goal of 90% adherence. T1 and T2 participants are required to reach 90% adherence by month 12 to participate in a larger prize drawing. The control group receives the usual standard of care. All four groups will receive weekly motivational messages; the three treatment groups will additionally receive reminders of their upcoming prize drawing. Adherence will be measured continuously throughout the intervention period using electronic devices and for 12 months post-intervention. Surveys will be conducted at baseline and every 6 months. Viral loads will be measured annually. The primary outcome is Wisepill-measured adherence and a binary measure for whether the person took at least 90% of their pills. The secondary outcome is the log-transformed viral load as a continuous measure. DISCUSSION: Our study is one of the first to apply insights about the psychology and behavioral economics of goal-setting to the design of incentives, by testing whether conditioning the eligibility threshold for incentives on subgoals (interim goals leading up to the ultimate, high goal) improves motivation and adherence more than setting a uniformly highly goal, and a comparison group. TRIAL REGISTRATION: ClinicalTrials.gov NCT05378607. Date of registration: May 18, 2022.

Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Nonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. OBJECTIVE: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. METHODS: A sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention. RESULTS: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. CONCLUSIONS: This study is the first to use behavioral economics-based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process. TRIAL REGISTRATION: ClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42216.

Palliative care needs of HIV exposed and infected children admitted to the inpatient paediatric unit in Uganda.

UNLABELLED: Paediatric palliative care is an emerging subspecialty that focuses on achieving the best possible quality of life for children with life-limiting conditions and also for their families. It is a response to the suffering and unique needs of such children. Globally there is limited documented data available on the palliative care needs of children with HIV. A retrospective review of data of all the HIV exposed and positive children who were admitted to the ward from January to December 2012 was done to document their palliative care needs. A total of 243 children were admitted to the ward during the stated period. Of these, 139 (57.2%) were female and 104 (42.8%) were male. Among them 131 (54%) were aged five years and below whereas 112 (46%) were above five years. Some of the identified palliative care needs documented included physical needs: pneumonia 46 (19%), severe acute malnutrition 38 (16%), mild and moderate acute malnutrition 23 (9.6%), and respiratory tract infections 22 (9.3%). Social needs: poor social support 21 (41%), financial instability 16 (31%), and child neglect 4 (8%). Psychological needs: antiretroviral treatment (ART) counselling 127 (36%), HIV counselling and testing for the child and family 63 (18%), adherence support 53 (15%), and others 11 (3%). Spiritual needs: discontinuing ART because of belief in spiritual healing 18 (81%), loss of hope because of severe ill health 1 (5%), and others 3 (14%). These results emphasise the need for palliative care in children with HIV even in the era of ART. The needs identified are in keeping with studies done elsewhere and are similar to the palliative care needs of children with other life-limiting illnesses such as cancer. CONCLUSION: HIV positive and exposed children plus their families have vast palliative care needs and a holistic approach is the key in their management.

Increased mortality among HIV-positive men on antiretroviral therapy: survival differences between sexes explained by late initiation in Uganda.

BACKGROUND: We aimed to assess the relationship between gender and survival among adult patients newly enrolled on antiretroviral therapy (ART) in Uganda. We also specifically examined the role of antenatal services in favoring women's access to HIV care. METHODS: From an observational cohort study, we assessed survival and used logistic regression and differences in means to compare men and women who did not access care through antenatal services. Differences were assessed on measures of disease progression (WHO stage and CD4 count) and demographic (age, marital status, and education), behavioral (sexual activity, disclosure to partner, and testing), and clinical variables (hepatitis B and C, syphilis, malaria, and anemia). A mediational analysis that considered gender as the initial variable, time to death as the outcome, initial CD4 count as the mediator, and age as a covariate was performed using an accelerated failure time model with a Weibull distribution. RESULTS: Between 2004 and 2011, a total of 4775 patients initiated ART, and after exclusions 4537 (93.2%) were included in analysis. Men initiating ART were more likely to have a WHO disease stage III or IV (odds ratio: 1.46, 95% confidence interval [CI]: 1.29-1.66), and lower CD4 cell counts compared to women (median baseline CD4 124 cells/mm(3), interquartile range [IQR]: 43-205 versus 147 cells/mm(3), IQR: 68-212, P-value < 0.0001). Men were at an increased risk of death compared to women (hazard ratio: 1.38, 95% CI: 1.03-1.83). Baseline CD4 cell counts accounted for 43% of the increased risk of death in men (95% CI: 22%-113%). Access to care via antenatal services did not explain differences in outcomes. CONCLUSION: In this cohort there is a marked increase in risk of mortality for men and approximately half of it can be attributed to their later engagement in care. More effort is required to engage men in care in a timely manner.

Cohort profile: the MUg Observational Cohort.

Mildmay Uganda (MUg), an HIV treatment centre near Kampala, the capital of Uganda, has entered into a memorandum of understanding to collaborate with Canadian researchers at the University of Ottawa to develop their research programme and develop an observational cohort database (the MUg observational cohort). The primary objectives of the MUg observational cohort are to monitor clinical care and outcomes of HIV among patients on treatment and to bring awareness to trends that are functional and dysfunctional in HIV care in Uganda. The MUg observational cohort comprises 8835 individuals who initiated combination antiretroviral therapy at MUg between January 2004 and October 2011. There are considerably more women (63.2%) than men in the cohort, and age spans from newborn to 92 years old. The low median age of 31 years (interquartile range: 18-38 years) can be explained by the 24.9% of the cohort aged <18 years. The median baseline CD4 cell count among the entire cohort is 172 cells/mm(3) (interquartile range: 73-249 cells/mm(3)). Data are routinely completed at treatment initiation, and follow-up data are collected routinely through physician visits and laboratory results. Data comprise demographic, behavioural and clinical variables. Collaborations and enquiries relating to the MUg observational cohort are encouraged, and can be addressed to Dr Edward Mills at edward.mills@uottowa.ca.