Family Connections randomized controlled trial: assessing the feasibility and acceptability of an intervention with adolescents living with HIV and their caregivers in Ndola, Zambia.

Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed Family Connections as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs (n = 100) of adolescents (15-19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend Family Connections to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this Family Connections pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups.

Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial.

BACKGROUND: Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. METHODS: We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. FINDINGS: Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. INTERPRETATION: Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. FUNDING: US National Institutes of Health.

Factors Related to Incomplete Adherence to Antiretroviral Therapy among Adolescents Attending Three HIV Clinics in the Copperbelt, Zambia.

Little is known about adherence to antiretroviral therapy (ART) among adolescents in sub-Saharan Africa, where the majority of the world's HIV-positive adolescents reside. We assessed individual, household, and HIV self-management characteristics associated with a 48-hour treatment gap in the preceding 3 months, and a pharmacy medication possession ratio (MPR) that assessed the number of ART pills dispensed divided by the number of ART pills required in the past 6 months, among 285 Zambians, ages 15-19 years. Factors significantly associated with a 48-hour treatment gap were being male, not everyone at home being aware of the adolescent's HIV status, and alcohol use in the past month. Factors associated with an MPR < 90% included attending the clinic alone, alcohol use in the past month, and currently not being in school. Findings support programs to strengthen adolescents' HIV management skills with attention to alcohol use, family engagement, and the challenges adolescents face transitioning into adulthood, especially when they are no longer in school.

Differences in Cervical Cancer Screening Knowledge and Practices by HIV Status and Geographic Location: Implication for Program Implementation in Zambia.

The knowledge and perceptions of cervical cancer among HIV negative and positive women, aged 25-49 years, from rural and urban locations in Zambia was systematically accessed in this study to determine any differences. Data were coded and analyzed using NVivo software. Compared to HIV negative women, HIV positive women had more accurate information about cervical cancer. They were more likely to cite male circumcision as the best approach to cervical cancer prevention. HPV infection was more commonly mentioned as a risk factor among HIV positive women. However, HIV positive women displayed little knowledge about HPV being the major cause of cervical cancer. Among HIV positive women, lack of time was the major screening barrier cited while HIV negative women mentioned being symptomatic as a determinant for early detection. Compared to rural residents, urban residents cited a wider range of cervical cancer information sources, including media and workplace although all of the participants who stated that they had no knowledge of cervical cancer were urban residents. Overall, knowledge and perceptions of cervical cancer among study participants was high, although differences exist between subgroups. Sharing accurate and standardized information on cervical cancer would improve participation in cervical cancer screening services.

Is Male Involvement in ANC and PMTCT Associated with Increased Facility-Based Obstetric Delivery in Pregnant Women?

Ensuring that pregnant women are delivering in a health facility and are attended to by skilled birth attendants is critical to reducing maternal and infant morbidity and mortality. This study sought to determine the associations between male involvement in antenatal care (ANC) services and pregnant women delivering at health facilities and being attended to by skilled birth attendants as well as attending postnatal care. This was a retrospective cohort study using secondary analysis of program data. We reviewed health records of all pregnant women who attended antenatal services irrespective of HIV status between March and December 2012 in 10 health facilities in three provinces of Zambia. An extraction questionnaire was used to collect sociodemographic and clinical information from registers used in services for maternal neonatal child health as well as delivery. Using logistic regression, we calculated the odds ratios (OR) and 95% confidence intervals (CI) of the association between (1) male involvement and delivery at a health facility by a skilled birth attendant and (2) male involvement and women's attendance at postnatal services. We found that more women who had been accompanied by their male partner during ANC delivered at a health facility than those who had not been accompanied (88/220 = 40% vs. 543/1787 = 30.4%, respectively; OR 1.53, 95% CI: 1.15-2.04). Also, we noted that a greater proportion of the women who returned for postnatal visits had been accompanied by their partner at ANC visits, compared to those women who came to ANC without their partner (106/220 = 48.2% vs. 661/1787 = 37.0%, respectively; OR 1.58, 95% CI: 1.20-2.10). Male involvement seems to be a key factor in women's health-seeking behaviours and could have a positive impact on maternal and infant morbidity and mortality.

A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial.

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority (P = 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision.ClinicalTrials.gov registration: NCT02956239 .

Prevalence of self-reported diabetes risk factors and integration of diabetes screening and referral at two urban HIV care and treatment clinics in Zambia.

People living with HIV (PLWH) on antiretroviral therapy (ART) are living longer and are at risk of HIV co-morbidities including non-communicable diseases (NCDs), particularly in low-resource settings. However, the evidence base for effectively integrating HIV and NCD care is limited. The Chronic Health Care (CHC) checklist, designed to screen for multiple NCDs including a 6-item diabetes self-report screener, was implemented at two PEPFAR-supported HIV clinics in Kabwe and Kitwe, Zambia. Study objectives were to describe the HIV care and treatment population and their self-reported diabetes-related symptoms, and to evaluate provider-initiated screening and referral post-training on the CHC checklist. This cross-sectional study enrolled 435 adults receiving combination ART services. Clinic exit interviews revealed 46% self-reported at least one potential symptom, and 6% self-reported three or more symptoms to the study team, indicating risk for diabetes and need for further diagnostic testing. In comparison, only 8% of all participants reported being appropriately screened for diabetes by their health provider, with less than 1% referred for further testing. This missed opportunity for screening and referral indicates that HIV-NCD integration efforts need more fully resourced and multi-pronged approaches in order to ensure that PLWH who are already accessing ART receive the comprehensive, holistic care they need.

Patient Preferences and Willingness to Pay for Cervical Cancer Prevention in Zambia: Protocol for a Multi-Cohort Discrete Choice Experiment.

BACKGROUND: Although most countries in southern Africa have cervical cancer screening programs, these programs generally fail to reach a significant majority of women because they are often implemented as pilot or research projects, and this limits their scope and ability to scale up screening. Some countries have planned larger-scale programs, but these have either never been implemented or have not been successfully scaled up. Most of the global burden of cervical cancer is experienced in countries with limited resources, and mortality from cervical cancer is the most common cause of cancer-related deaths among women in Sub-Saharan Africa. OBJECTIVE: The purpose of this study is to learn about preferences for cervical cancer screening in Zambia, to identify barriers and facilitators for screening uptake, and to evaluate willingness to pay for screening services to support the scaling up of cervical cancer screening programs. METHODS: We will conduct a discrete choice experiment by interviewing women and men and asking them to choose among constructed scenarios with varying combinations of attributes relevant to cervical cancer screening. To inform the discrete choice experiment, we will conduct focus groups and interviews about general knowledge and attitudes about cervical screening, perception about the availability of screening, stigma associated with cancer and HIV, and payment for health care services. For the discrete choice experiment, we will have a maximum design of 120 choice sets divided into 15 sets of 8 tasks each with a sample size of 320-400 respondents. We will use a hierarchical Bayesian estimation procedure to assess attributes at the following two levels: group and individual levels. RESULTS: The model will generate preferences for attributes to assess the most important features and allow for the assessment of differences among cohorts. We will conduct policy simulations reflecting potential changes in the attributes of the screening facilities and calculate the projected changes in preference for choosing to undergo cervical cancer screening. The findings from the discrete choice experiment will be supplemented with interviews, focus groups, and patient surveys to ensure a comprehensive and context-based interpretation of the results. CONCLUSIONS: Because willingness to pay for cervical cancer screening has not been previously assessed, this will be a unique and important contribution to the literature. This study will take into account the high HIV prevalence in Sub-Saharan Africa and prevailing gender attitudes to identify an optimal package of interventions to reduce cervical cancer incidence. This simulation of women's decisions (and men's support) to undergo screening will lay the foundation for understanding the stated preferences and willingness to pay to help design future screening programs. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10429.

Adolescents living with HIV in the Copperbelt Province of Zambia: Their reproductive health needs and experiences.

BACKGROUND: Understanding and meeting the reproductive health needs of adolescents living with HIV (ALHIV) is a growing concern since advances in antiretroviral therapy mean that many ALHIV are now living into adulthood and starting to have sex. METHODS: We conducted a mixed-methods study in the Copperbelt Province of Zambia to advance our understanding of the reproductive health needs of ALHIV and to assess the extent to which these needs are being met. We conducted in-depth interviews (IDIs) with 32 ALHIV from two HIV clinics, 23 with their caregivers, and 10 with clinic staff. ALHIV were interviewed twice. We used the data from the qualitative interviews to create a cross-sectional survey that we conducted with 312 ALHIV in three HIV clinics. FINDINGS: The vast majority of ALHIV reported they wanted to have children in the future but lacked knowledge about preventing mother-to-child transmission. Some sexually active adolescents used condoms, although they wanted more information about and access to non-condom methods. Many ALHIV reported that their first sexual encounters were forced. Religious beliefs prevented some caregivers from discussing premarital sex and contraception with ALHIV. Clinic staff and caregivers had mixed views about integrating contraceptive counseling and method provision into HIV care and treatment services. Few sexually active ALHIV reported that they disclosed their HIV status to their sexual partners and few reported that they knew their sexual partner's status. CONCLUSIONS: ALHIV are in dire need of comprehensive sexual and reproductive health services and information including a range of contraceptive methods to prevent pregnancy, knowledge about preventing mother-to-child transmission and having a healthy pregnancy, skills related to HIV disclosure and condom negotiation to prevent horizontal transmission, and screening for sexual violence for both males and females if services are available.

"The sky is the limit": adhering to antiretroviral therapy and HIV self-management from the perspectives of adolescents living with HIV and their adult caregivers.

INTRODUCTION: Worldwide, HIV-related mortality among adolescents living with HIV (ALHIV) increased by 50% from 2005 to 2012 and is attributed in part to a lack of support for adolescent retention to care and adherence to antiretroviral therapy (ART). This vulnerability reinforces the need to better understand incomplete ART adherence among ALHIV, particularly in sub-Saharan Africa, where the majority of the world's 2.1 million ALHIV reside. METHODS: From December 2011 to February 2012, we conducted in-depth interviews with 32 ALHIV (aged 15 to 18) and 23 of their adult caregivers in the Copperbelt Province of Zambia. Interviews were transcribed and translated. An iterative qualitative process was used to code and analyze the data and main themes were summarized regarding the barriers to and facilitators of ART adherence. RESULTS: More than a quarter of ALHIV reported missing a day or more of ART (ranging from one day to six months). Barriers to ART adherence included fear of disclosure and anticipated stigma. Few youth were willing to take their drugs outside of the home, which led to missed doses of ART. Similarly, families tended to manage HIV within the home only. As a result, although caregivers and families were often the greatest source of emotional and instrumental support, they coped with HIV in isolation of other potential support from their communities, schools or churches. Factors that supported ART adherence included attending clinic-sponsored youth groups, wanting to maintain one's health and using phone and clock alarms. Involvement of adult caregivers in HIV management varied greatly and was often based on the age and health status of the youth. Some caregivers struggled with letting the adolescents assume responsibility for their medication, and ALHIV had few self-management skills and tools to help them regularly take ART. CONCLUSIONS: These data highlight the importance of families and home environments in supporting adherence to ART among ALHIV. Skill-building and family-based interventions to prepare ALHIV and their adult caregivers for HIV self-management and HIV status disclosure by youth are of paramount importance. Future research and programmes also need to address the fears adolescents and families have regarding HIV-related stigma that shape young peoples' adherence behaviours.