Impact of internalized stigma on HIV prevention behaviors among HIV-infected individuals seeking HIV care in Kenya

In general, an initial diagnosis of HIV is likely to be correlated with the onset of HIV stigma. HIV-positive individuals are likely to internalize stigma, may suffer from psychosocial issues, or engage in maladaptive behaviors to cope with the diagnosis. Internalized stigma stems from fear of stigmatization also known as felt stigma. The current study examined the impact of HIV felt stigma on overall health and success of HIV prevention behaviors among 370 participants living with HIV and receiving care at an urban HIV clinic in Kenya. An 18-item instrument was cross culturally adapted to measure felt stigma. Descriptive and logistic regression analyses examined the data. Findings indicate that 25.9% (n=96) of participants who reported experiencing high levels of felt stigma related to other people's attitudes toward their condition, ostracizing, and a disruption of their personal life, were likely to not adhere to prescribed HIV medication and not disclose their HIV serostatus to one other person. Those who also experienced felt stigma related to a disruption of their personal lives while mediated by depression were likely to report poor overall health. Findings support having HIV clinics and interventions develop relevant HIV prevention strategies that focus on the emerging dimensions of felt stigma which can significantly impact disclosure of serostatus, medication adherence, and overall health

Implementation research : a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

AVAILABILITY OF DATA AND MATERIALS : The only individual with access to the full dataset during the conduction of the trial will be the statistician at FIND. At the end of the trial, site-specific data will be made available to the research teams at the trial sites. Reasonable requests for the trial data from academic parties will be considered by the corresponding author, and data may be made available in line with the data-sharing policies of FIND.BACKGROUND : Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS : This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION : This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION : NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.FIND, with a grant from The Leona M. and Harry B. Helmsley Charitable Trust.https://trialsjournal.biomedcentral.comhj2024Internal MedicinePaediatrics and Child HealthSchool of Health Systems and Public Health (SHSPH)SDG-03:Good heatlh and well-bein

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

Abstract Background Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. Methods This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). Discussion This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. Trial registration NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023

Safety, immunogenicity and efficacy of PfSPZ vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial

The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naive adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination. However, previous malaria exposure can limit immune responses and vaccine efficacy (VE) in adults. We hypothesized that infants with less previous exposure to malaria would have improved immunity and protection. We conducted a multi-arm, randomized, double-blind, placebo-controlled trial in 336 infants aged 5-12 months to determine the safety, tolerability, immunogenicity and efficacy of the PfSPZ Vaccine in infants in a high-transmission malaria setting in western Kenya ( NCT02687373 ). Groups of 84 infants each received 4.5 x 10(5), 9.0 x 10(5) or 1.8 x 10(6) PfSPZ Vaccine or saline three times at 8-week intervals. The vaccine was well tolerated; 52 (20.6%) children in the vaccine groups and 20 (23.8%) in the placebo group experienced related solicited adverse events (AEs) within 28 d postvaccination and most were mild. There was 1 grade 3-related solicited AE in the vaccine group (0.4%) and 2 in the placebo group (2.4%). Seizures were more common in the highest-dose group (14.3%) compared to 6.0% of controls, with most being attributed to malaria. There was no significant protection against P. falciparum infection in any dose group at 6 months (VE in the 9.0 x 10(5) dose group = -6.5%, P = 0.598, the primary statistical end point of the study). VE against clinical malaria 3 months after the last dose in the highest-dose group was 45.8% (P = 0.027), an exploratory end point. There was a dose-dependent increase in antibody responses that correlated with VE at 6 months in the lowest- and highest-dose groups. T cell responses were undetectable across all dose groups. Detection of Vdelta2(+)Vgamma9(+) T cells, which have been correlated with induction of PfSPZ Vaccine T cell immunity and protection in adults, were infrequent. These data suggest that PfSPZ Vaccine-induced T cell immunity is age-dependent and may be influenced by Vdelta2(+)Vgamma9(+) T cell frequency. Since there was no significant VE at 6 months in these infants, these vaccine regimens will likely not be pursued further in this age group