A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Lessertia frutescens (L.) Goldblatt and J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.) in HIV-infected South Africans : Protocol

Protocol Number: TICIPS002_RP01NIH: National Center for Complementary and Alternative MedicinesFogarty International CenterSponsor: National Center for Complementary and Alternative Medicine National Institutes of Health (http://nccam.nih.gov)On July 9, 2015, the file was updated from the 2009-12 version to Version 7.5 (Protocol Revision Date April 05, 2010)

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial

Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation. Discussion This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline. Trial registration ClinicalTrials.gov NCT01188018http://deepblue.lib.umich.edu/bitstream/2027.42/112923/1/12889_2012_Article_4312.pd

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: Study protocol of a randomized, controlled, efficacy trial.

Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation. Discussion This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline. Trial registration ClinicalTrials.gov NCT01188018Peer Reviewe

The Association Between Poor Antiretroviral Adherence and Unsafe Sex: Differences by Gender and Sexual Orientation and Implications for Scale-up of Treatment as Prevention

Non-adherence to safer sex and non-adherence to ART can each have adverse health consequences for HIV-infected individuals and their sex partners, but little is known about the association of these behaviors with each other. This “dual risk” has potential negative public health consequences since non-adherence can lead to the development of resistant virus that can then be transmitted to sex partners

A Qualitative Examination of the Indirect Effects of Modified Directly Observed Therapy on Health Behaviors Other Than Adherence

Modified directly observed therapy (mDOT), in which a portion of doses in a medication regimen are ingested under supervision, has had some demonstrated success in improving the high levels of adherence necessary to achieve maximum benefit from antiretroviral medications. Consistent with the Information-Motivation-Behavioral skills (IMB) model, mDOT's success is likely due to its direct impact on patients' knowledge, motivation, and behaviors related to adherence. However, mDOT's potential impact on patients' information, motivation, and behaviors related to health activities other than adherence to antiretroviral medications has not been explored. Data from participants enrolled in Project MOTIV8, a randomized controlled trial to test the efficacy of novel behavioral adherence interventions, were analyzed to explore the potential impact of mDOT on health behaviors other than adherence. Participants were recruited from local HIV clinics from 2004–2008. Thirty-four percent of those approached, agreed to participate in the study. Data from all participants randomized to the mDOT intervention arm thus far (n = 50, mean age 39.7 standard deviation [SD] = 9.0, 78% male 64% African American, and 86% infected via sexual transmission) were included. Overall, participants reported a high level of satisfaction with the mDOT intervention. Qualitative data revealed that mDOT had a positive impact on participants' adherence to nonantiretroviral medications as well as their involvement and communication with health care providers. In addition, participants reported that the daily mDOT visits had indirect effects on their daily functioning, including improvements in their daily living activities (e.g., earlier awakenings, getting dressed, and cleaning their homes) and an increased level of community involvement

High report of miscarriage among women living with HIV who want to conceive in Uganda

Abstract Objective Data on early miscarriage incidence is limited due to various social and methodological barriers. We report on 24-month pregnancy outcomes of 299 female Ugandan HIV clients in committed relationships with an intention to conceive. Miscarriage data are reported as auxiliary findings to a larger study (5R01HD072633). Results 127 (42%) participants reported a pregnancy during the study; among the remaining 172, 82 indicated they stopped trying to conceive, and 16 dropped out prior to month 24. Of the 127 pregnancies, 55 (43%) resulted in live births, 67 (53%) in spontaneous miscarriage, 1 (< 1%) in stillbirth, 1 (< 1%) in abortion, and 3 (2%) in unknown outcomes. Three-quarters (75%) of miscarriages for which time until miscarriage was available were reported to occur in the first trimester (mean = 11.3 weeks gestation). The 67 participants who reported a miscarriage tended to be older (mean 33 vs. 30 years), but the significance of age did not persist after adjusting for multiple tests. We observed relatively low rates of pregnancy and high rates of miscarriage among this cohort of HIV-positive women wanting to conceive. Rigorously designed studies are needed to better understand the observed high rate of early miscarriage among HIV-infected women

Utilization of prevention of mother-to-child transmission (PMTCT) services among pregnant women in HIV care in Uganda: a 24-month cohort of women from pre-conception to post-delivery

Abstract Objective We assessed the uptake of prevention of mother-to-child transmission (PMTCT) services in a cohort of HIV infected women in care at The AIDS Support Organization Jinja and Kampala in Uganda, who were trying to conceive, over a period of 24 months, to inform the strengthening of PMTCT service access for women in care. Results Of the 299 women 127 (42.5%) reported at least one pregnancy within 24 months; 61 women (48.0%) delivered a live child. Of the 55 who had a live birth at the first pregnancy, 54 (98.2%) used antenatal care (ANC) starting at 15.5 weeks of gestation on average and 47/49 (95.9%) delivered at a health facility. Excluding miscarriages, 54 (98.2%) received ARVs during pregnancy. Of the 49 live births with post-delivery data, 37 (75.5%) tested the infant for HIV. 79 of the 127 (68.7%) spoke with providers about childbearing. Communication with providers was associated with ANC use (65.8% vs. 41.7%; p = .015). Despite the high rate of miscarriages and late ANC start, this study shows very high uptake of PMTCT services among PLHIV in care and their infants. Improved provider–client communication could enhance ANC attendance and PMTCT outcomes among HIV infected women in care