Standard of care for social harms in HIV prevention trials: A South African perspective.

BACKGROUND: The prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports. METHODOLOGY: This paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such reports. RESULTS: This review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal. CONCLUSION: Social harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence-based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials.

Improvement in Muscular Strength in HIV-Infected Individuals Receiving Antiretroviral Therapy.

PURPOSE: This study investigated (1) the effect of a progressive resistance training (PRT) program and whey protein intake on maximal muscle strength in human immunodeficiency virus (HIV)-infected individuals receiving antiretroviral therapy (ART) and (2) alterations in maximal strength 12 wks after the cessation of PRT with continued supplementation. METHODS: Sixty HIV-infected individuals were recruited. Whole body PRT was performed twice weekly for 12 wks. Participants received, in a double-blind placebo controlled manner, either 20 g whey or placebo (maltodextrin) before and immediately after each session. Both PRT groups continued to take either whey protein or placebo for a further 12 wks following the exercise intervention to examine the effects of detraining. RESULTS: Forty participants (mean and standard deviation (SD) age 40.8 (±7.7) years, weight 70.8 (±16) kg, body mass index (BMI) 30.9 (±7.2) kg m2); whey protein /PRT (n = 13), placebo/PRT (n = 17), and a control group (n = 10) completed the study. A significant main effect for time occurred for the bench press (p = 0.02), the squat (p < 0.0001), the deadlift (p = 0.001) and the shoulder press (p = 0.02) one-repetition maximum (1RM) in the intervention groups. CONCLUSION: The PRT program increased maximal strength regardless of whey protein intake. The detraining period demonstrated minimal strength loss, which is beneficial to this population.

Heart rate variability in physically active individuals: reliability and gender characteristics.

PURPOSE: To evaluate the reliability of short-term recordings (five minutes) of heart rate variability (HRV) and the association between HRV and gender. METHODS: HRV time- and frequency-domain parameters were calculated in 44 physically active students (21 males and 23 females) over four consecutive days. A Suunto t6 heart rate monitor was used to obtain inter-beat intervals (IBIs) that were then transferred to Kubios HRV analysis software. The relative reliability [intra-class correlation (ICC)] and absolute reliability, [typical error of measurement (TEM) and typical error of measurement as a percentage (TEM%)] of the HRV parameters were then calculated for day 2 versus day 3 and day 3 versus day 4, with day 1 being a familiarisation day. The following HRV parameters were calculated: (1) time domain: resting heart rate (RHR), R-R intervals (IBI), standard deviation of normal-to-normal intervals (SDNN), root mean square differences of the standard deviation (RMSSD), percentage of beats that changed more than 50 ms from the previous beat (pNN50); and (2) frequency domain: low-frequency normalised units (LFnu), high-frequency normalised units (HFnu), low-frequency to high-frequency ratio in normalised units (LF/HFnu). An analysis of variance (ANOVA) with Tukey post-hoc testing was performed to compare HRV parameters in males and females. Significance was set at p ≤ 0.05. RESULTS: The ICCs for both relationship 1 and 2 indicated primarily good to excellent (> 0.8) relative reliability. The lowest value was found in the LF/HFnu ratio (ICC = 0.36) for males. Absolute reliability was low with TEM% greater than 10% for all HRV parameters, except IBIs. Females demonstrated better relative (higher ICCs) and absolute reliability (lower TEM and TEM% ) compared to males for the frequency domain. The relative and absolute reliability for the time domains were similar except for SDNN where the absolute reliability was higher in males. ANOVA illustrated significant gender differences for the LF/HFnu ratio (41% higher in males, p = 0.003), HFnu (12% higher in females, p = 0.02) and IBI (21% higher in females, p < 0.0001). CONCLUSIONS: Short-term recordings of HRV over three consecutive days demonstrated a high relative reliability. However, a low absolute reliability indicated large day-to-day random variation in HRV, which would make the detection of intervention effects using HRV difficult in individual participants. Females were shown to have a higher parasympathetic modulation of HRV, which may indicate an underlying cardioprotective mechanism in females compared to males.