Corrigendum: How might we motivate uptake of the Dual Prevention Pill? Findings from human-centered design research with potential end users, male partners, and healthcare providers.

[This corrects the article DOI: 10.3389/frph.2023.1254953.].

How might we motivate uptake of the Dual Prevention Pill? Findings from human-centered design research with potential end users, male partners, and healthcare providers.

Introduction: Multipurpose prevention technologies (MPTs) combining contraception with HIV prevention offer a promising solution to uptake and adherence challenges faced with oral pre-exposure prophylaxis (PrEP). The Dual Prevention Pill (DPP), which combines oral PrEP with an oral contraceptive pill (OCP), could address unmet need for family planning (FP) and HIV prevention. This study aimed to identify barriers and motivators for DPP uptake to inform the development of a DPP demand generation strategy and broader introduction efforts for MPTs. Materials and methods: Qualitative, ethnographic research employing human-centered design techniques was conducted in Kenya, South Africa, and Zimbabwe. A research consortium conducted 45 immersions, 34 key informant interviews, and 12 friendship circles with potential end users, male romantic partners, healthcare providers (HCPs), and cultural commentators. Creative concepts were subsequently co-created and validated in workshops with end users, male partners, and HCPs. Results: Four major themes emerged. Women struggled to balance personal motivations with societal expectations. Relationship goals strongly influenced sexual and reproductive health decisions, particularly related to financial security and social status. Negative experiences, such as untrustworthy partners, were significant triggers for OCP and PrEP use. Lastly, male partners were concerned about the DPP upending gender norms but held more positive individual attitudes. Five initial audience segments for the DPP were identified: women seeking enjoyment outside of their primary relationship; new mothers adhering to social norms; women wanting to maintain romantic relationships; women at risk of unintended pregnancy; and women with unfaithful partners. Segments informed the development of three communication themes, with the preferred route highlighting the DPP as a tool to prepare for life's unpredictability. Discussion: To effectively generate demand for the DPP, several strategies should be considered. Connecting with women's diverse identities and goals and celebrating their individuality is crucial. Linking the DPP to relationship goals reframes it as a means to protect relationships rather than a risk. Leveraging negative triggers through targeted media campaigns empowers women to take control of their sexual health during challenging moments. A balance in channel placement is necessary to raise public awareness while using more discrete channels for potentially controversial messages with male partners and wider communities.

Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond.

Introduction: The pipeline for multi-purpose prevention technologies includes products that simultaneously prevent HIV, pregnancy and/or other sexually transmitted infections. Among these, the Dual Prevention Pill (DPP) is a daily pill co-formulating oral pre-exposure prophylaxis (PrEP), and combined oral contraception (COC). Clinical cross-over acceptability studies for the DPP require training providers to counsel on a combined product. From February 2021-April 2022, a working group of eight HIV and FP experts with clinical and implementation expertise developed counseling recommendations for the DPP based on existing PrEP/COC guidance. Assessment of policy/guidelines options and implications: The working group conducted a mapping of counseling messages from COC and oral PrEP guidance and provider training materials. Six topics were prioritized: uptake, missed pills, side effects, discontinuation and switching, drug interactions and monitoring. Additional evidence and experts were consulted to answer outstanding questions and counseling recommendations for the DPP were developed. Missed pills was the topic with the most complexity, raising questions about whether women could "double up" on missed pills or skip the last week of the pack to recover protection faster. Uptake required aligning the time to reach protective levels for both DPP components and explaining the need to take DPP pills during week 4 of the pack. The potential intensity of DPP side effects, given the combination of oral PrEP with COC, was an important consideration. Discontinuation and switching looked at managing risk of HIV and unintended pregnancy when stopping or switching from the DPP. Guidance on drug interactions contended with differing contraindications for COC and PrEP. Monitoring required balancing clinical requirements with potential user burden. Actionable recommendations: The working group developed counseling recommendations for the DPP to be tested in clinical acceptability studies. Uptake: Take one pill every day for the DPP until the pack is empty. Days 1-21 contain COC and oral PrEP. Days 22-28 do not contain COC to allow for monthly bleeding, but do contain oral PrEP and pills should be taken to maintain HIV protection. Take the DPP for 7 consecutive days to reach protective levels against pregnancy and HIV. Missed pills: If you miss 1 pill multiple times in a month or 2+ consecutive pills, take the DPP as soon as you remember. Do not take more than 2 pills in a day. If 2+ consecutive pills are missed, only take the last missed pill and discard the other missed pills. Side effects: You may experience side effects when you start using the DPP, including changes to monthly bleeding. Side effects are typically mild and go away without treatment. Discontinuation/switching: If you decide to discontinue use of the DPP, but want to be protected from HIV and/or unintended pregnancy, in most cases, you can begin using PrEP or another contraceptive method right away. Drug interactions: There are no drug-drug interactions from combining oral PrEP and COC in the DPP. Certain medications are not recommended due to their contraindication with oral PrEP or COC. Monitoring: You will need to get an HIV test prior to initiating or restarting the DPP, and every 3 months during DPP use. Your provider may recommend other screening or testing. Discussion: Developing recommendations for the DPP as a novel MPT posed unique challenges, with implications for efficacy, cost, and user and provider comprehension and burden. Incorporating counseling recommendations into clinical cross-over acceptability studies allows for real-time feedback from providers and users. Supporting women with information to use the DPP correctly and confidently is critically important for eventual scale and commercialization.

Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment.

The HIV pandemic has long revealed the inequities and fault lines in societies, one of the most tenacious being the pandemic's disproportionate impact on adolescent girls and young women. In east and southern Africa, renewed global action is needed to invigorate an effective yet undervalued approach to expanding HIV prevention and improving women's health: integration of quality HIV and sexual and reproductive health (SRH) services. The urgency of advancing effective integration of these services has never been clearer or more pressing. In this piece, national health officials from Kenya, Malawi, and Zimbabwe and global health professionals have joined together in a call to catalyze actions by development partners in support of national strategies to integrate HIV and SRH information and services. This agenda is especially vital now because these adolescent girls and young women are falling through the cracks due to the cascading effects of COVID-19 and disruptions in both SRH and HIV services. In addition, the scale-up of pre-exposure prophylaxis (PrEP) has been anemic for this population. Examining the opportunities and challenges of HIV/SRH integration implemented recently in three countries - Kenya, Malawi, and Zimbabwe - provides lessons to spur integration and investments there and in other nations in the region, aimed at improving health outcomes for adolescent girls and young women and curbing the global HIV epidemic. While gaps remain between strong national integration policies and program implementation, the experiences of these countries show opportunities for expanded, quality integration. This commentary draws on a longer comparative analysis of findings from rapid landscaping analyses in Kenya, Malawi, and Zimbabwe, which highlighted cross-country trends and context-specific realities around HIV/SRH integration.

A novel smoking-specific self-control task: An initial study of feasibility, acceptability, and changes in self-control and cigarette smoking behaviors among adults using cigarettes.

Objective: Self-control is a key factor in quitting cigarettes and practicing general self-control tasks may strengthen self-control. This study examined the feasibility and acceptability of a novel smoking-related self-control task. Method: Seventy-five adults with current cigarette smoking (Mage = 44.8, 74.7% male, 63.5% Black, 74.3% non-Latinx) were randomly assigned to practice a smoking-specific self-control task (Delay Smoking Task, n = 39) or a general self-control task (Posture Task, n = 36) for 1 week. Assessments included cigarettes per day (CPD), motivation to quit smoking, self-control, and task acceptability. Results: Most participants completed both appointments with no difference between task groups (p = .69). The Delay Smoking Task group rated the task as more difficult (p = .04) and more helpful for quitting smoking (p = .005) than did the Posture Task group. Self-control task groups did not differ in task effort (p = .66), task success (p = .14), or self-control used to practice the task (p = .13). Both task groups reported increased quit desire, expected quit success, quit confidence, and quit motivation (p < .05; partial η²s = 0.108-0.333). The time by task group interaction approached significance for expected quit success (p = .06; partial η² = .053), with the Delay Smoking Task group showing greater increases than the Posture Task group. Over the week, smoking decreased an average of 1.0 CPD with no difference between groups (p = .72; partial η² = 0.165). Conclusions: Practicing self-control was associated with increases in motivation to quit, confidence in quitting, and expected success at quitting smoking with similar changes for those practicing a smoking-specific versus a general self-control task. Self-control tasks may be useful for increasing motivation to quit cigarettes. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Correlations between oral Pre-Exposure Prophylaxis (PrEP) initiations and policies that enable the use of PrEP to address HIV globally.

Policies facilitating access to HIV prevention services, specifically for pre-exposure prophylaxis (PrEP), can foster enabling environments for service uptake. This analysis aims to establish whether policies enabling broad PrEP eligibility, HIV self-testing, and lowered age of consent to HIV testing and treatment services are correlated with PrEP uptake. Ages of consent vary by country, therefore this analysis focused on how age of consent policies, in general, affect adolescent PrEP uptake. Data was collected from the HIV Policy Lab and AVAC's Global PrEP Tracker, a database of approximately 334 PrEP projects operating across 95 countries, and linear regression and correlation analyses were conducted via STATA to examine relationships amongst national oral PrEP eligibility, HIV self-testing, lowered age of consent, and national cumulative oral PrEP initiations, as of December 2021. Of all 194 countries tracked by the HIV Policy Lab, only about 7% have adopted all three policies (HIV self-testing, lowered age of consent, and PrEP eligibility policies). Less than 50% have adopted have adopted at least one of these policies. Of the 54 countries that have fully adopted PrEP eligibility policies, less than 30% have co-adopted HIV self-testing or lowered age of consent policies. About 30% of these 194 countries have yet to adopt any of these policies, of which about 14% have indicated information is "unavailable" for at least one of the policies. Analyses conducted for the 91 countries tracked by both the HIV Policy Lab and the Global PrEP Tracker revealed a significant and positive relationship between cumulative individuals initiated on oral PrEP and adoption of HIV self-testing policies (p = 0.01, r = 0.26), lowered age of consent policies (p = 0.01, r = 0.25), and PrEP eligibility policies (p = 0.01, r = 0.26). Stronger advocacy efforts towards approving public health policies, such as those outlined in our analysis, that enshrine and enable access to HIV prevention are necessary.

Self-control and smoking in a sample of adults living with HIV/AIDS: A cross-sectional survey.

INTRODUCTION: Cigarette smoking prevalences are very high in persons living with HIV (PLWH). Identifying variables among PLWH that are linked to smoking in community samples (e.g., self-control) can inform smoking treatments for PLWH. The current study examined the association of self-reported self-control and smoking (e.g., smoking status, cigarette dependence) in a sample of PLWH. METHODS: Adult PLWH were recruited from the Center for Positive Living (Montefiore Medical Center, Bronx, New York, US). All participants completed measures of demographics, cigarette smoking, and self-control. Participants who reported current cigarette smoking completed measures of cigarette dependence; intolerance for smoking abstinence; and motivation, confidence, and desire to quit smoking. RESULTS: The overall sample included 285 PLWH (49.1% cigarette users, 55.4% male, 52.7% Black race, 54.8% Latino/a ethnicity). PLWH with current cigarette smoking reported lower self-control than PLWH with no current cigarette smoking (M = 116.88, SD = 17.07 versus M = 127.39, SD = 20.32; t = -4.15, df = 211, p < 0.001). Among PLWH with current cigarette smoking, lower self-control was associated with greater cigarette dependence (ρ = -0.272, p < 0.01), and lower confidence in quitting smoking cigarettes (ρ = 0.214, p < 0.05). Lower self-control was associated with greater overall smoking abstinence intolerance (ρ = -0.221, p < 0.05) and withdrawal intolerance (ρ = -0.264, p < 0.01). DISCUSSION: Among a sample of PLWH, lower self-control was related to cigarette smoking (versus no smoking), greater cigarette dependence, lower confidence in quitting smoking, and greater intolerance for smoking abstinence. It may be useful to target self-control among PLWH to increase confidence in quitting and abstinence intolerance with the goal of improving smoking cessation outcomes.

Integration of HIV prevention and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe.

Background: Though substantial progress has helped curb the HIV epidemic, high rates of new HIV infections persist among adolescent girls and young women (AGYW) in sub-Saharan Africa, reflecting critical gaps in reaching them with integrated HIV prevention and sexual and reproductive health (SRH) services. The scale-up of oral pre-exposure prophylaxis (PrEP) and multiple novel HIV prevention products on the horizon offer countries a unique opportunity to expand innovative approaches to deliver comprehensive, integrated HIV prevention/SRH services. Methods: This article comparatively analyzes findings from rapid assessments in Kenya, Malawi and Zimbabwe across key themes to highlight cross-country trends and contextual realities around HIV prevention/SRH integration, with a focus on oral PrEP and contraception. In Kenya and Zimbabwe, assessments were completed by Ministries of Health (MOH) and the HIV Prevention Market Manager and include 20 health facility assessments, 73 key informant interviews (KIIs) and six community dialogues. In Malawi, the assessment was completed by the MOH and Georgetown University Center for Innovation in Global Health and includes 70 KIIs and a review of national policies and program implementation in Blantyre. Findings were contextualized through a review of literature and policies in each country. Results: Across countries, the policy environment is conducive to HIV prevention/SRH integration, though operationalization presents ongoing challenges, with most policies preceding and not accounting for oral PrEP rollout. National coordination mechanisms, youth-friendly health services and prevention of mother-to-child transmission programs are promising practices, while siloed and resource-constrained health systems, limited provider capacity, underfunded demand generation and structural factors exacerbate barriers to achieving integration. Conclusions: As new HIV prevention products are introduced, demand for integrated HIV prevention/SRH services is likely to grow. Investing in HIV prevention/SRH integration can help to ensure a sustainable response to the HIV epidemic, streamline service delivery and improve the health outcomes and lives of AGYW.

Cigarette Smoking Behaviors and Beliefs in Persons Living With Hepatitis C.

BACKGROUND AND RATIONALE: Tobacco use is common among persons living with hepatitis C (PLHC), yet little is known about their smoking behaviors and beliefs. Modern hepatitis C treatment offers a unique opportunity to intensively engage this population about other health risks, including smoking. MAIN RESULTS: Seventy-seven tobacco users (40 hepatitis C virus [HCV] seropositive and 37 HCV seronegative) enrolled in an interview study in a New York City clinic. The mean age was 51.6, 57.1% were male, 40.3% Latino, and 49.4% black. 67.5% were single and 18.2% were employed. HCV+ smokers differed from HCV- smokers in having a higher prevalence of illicit substance use, depression, and hypertension. PLHC smokers were highly motivated to quit, with 52.5% stating an intention to quit within 30 days. Most of the PLHC smokers had used cessation-directed pharmacotherapy, but almost none had tried a quitline or a quit smoking website. PLHC smokers scored higher on the intrapersonal locus of control subscale. Almost a quarter (22.5%) believed that smoking "helped fight the HCV." CONCLUSIONS: PLHC smokers have a high burden of psychiatric and substance use comorbidity. They exhibit characteristics that distinguish them from uninfected smokers, and many harbor false beliefs about imagined benefits of smoking. They are highly motivated to quit but underutilize cessation aids. Without aggressive intervention, smoking-related morbidity will likely mute the health benefits and longevity gains associated with hepatitis C treatment. Research such as this may prove useful in guiding the development of future tobacco treatment strategies. IMPLICATIONS: This is the first paper to examine, in detail, sociobehavioral correlates of tobacco use in PLHC. PLHC are recognized by the Department of Health and Human Services as a high-priority health disparities population. We are not aware of any tobacco treatment services designed specifically for PLHC. The first step in designing an intervention is defining the characteristics of the target group. Our findings will begin to address this need, and may prove useful in optimizing tobacco treatment strategies for smokers living with hepatitis C.

Barriers to Telephone Quitline Use Among Methadone-Maintained Smokers.

INTRODUCTION: Drug users have high rates of tobacco use and tobacco-related disease. Telephone quitlines promote smoking cessation, but their reach among drug users is unknown. We thus aimed to assess utilization of and barriers to telephone quitlines among methadone-maintained smokers. METHODS: Subjects were opioid-dependent smokers in Bronx, New York, methadone treatment programs who were enrolled in a clinical trial of varenicline. All subjects were offered referral to a free, proactive quitline. We examined quitline records, surveyed barriers to quitline use, and queried reasons for declining referral. RESULTS: Of the 112 subjects enrolled, 47% were male, 54% were Hispanic, and 28% were Black. All subjects were offered referral, and 25 (22% of study participants) utilized the quitline. Quitline utilizers (vs. nonutilizers) were significantly more likely to have landline phone service (72 vs. 42%, p = .01), interest in quitline participation (92 vs. 62%, p < .01), and willingness to receive calls (96 vs. 76%, p = .02). Nonutilizers were significantly more likely to report cell phone service lapse (38 vs. 14%, p = .04), and difficulty charging cell phones (19 vs. 0%, p = .02). Reasons for quitline refusal included: (a) skepticism of quitline efficacy; (b) aversion to telephone communication; (c) competing life demands (e.g., drug treatment, shelter); and (d) problems with cell phone service or minutes. CONCLUSIONS: Despite several limitations to quitline access among methadone-maintained smokers, routine quitline referral was associated with 22% utilization. To expand provision of smoking cessation treatment to opioid-dependent smokers, interventions to promote routine quitline referral in substance abuse treatment programs warrant investigation.

Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics.

BACKGROUND: Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment. METHODS/DESIGN: We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models. DISCUSSION: This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01378858.

Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial.

AIMS: To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. DESIGN: Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1 mg twice daily (n = 57) or matched placebo (n = 55), with in-person and telephone counseling. SETTING: Urban methadone programs in the Bronx, New York City, New York, USA. PARTICIPANTS: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. MEASUREMENTS: Seven-day point prevalence abstinence verified by expired carbon monoxide (CO) < 8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). FINDINGS: Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P = 0.03; effect size 10.5%, 95% confidence interval (CI) = 4.4-19.3%) and to reduce smoking (median five versus two cigarettes/day, P < 0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR= 0.84, 95% CI = 0.16, 4.4) and suicidality [odds ratio (OR) = 0.88, 95% CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. CONCLUSIONS: Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.