The influence of interviewers on survey responses among female sex workers in Zambia.

BACKGROUND: Interviewers can substantially affect self-reported data. This may be due to random variation in interviewers' ability to put respondents at ease or in how they frame questions. It may also be due to systematic differences such as social distance between interviewer and respondent (e.g., by age, gender, ethnicity) or different perceptions of what interviewers consider socially desirable responses. Exploration of such variation is limited, especially in stigmatized populations. METHODS: We analyzed data from a randomized controlled trial of HIV self-testing amongst 965 female sex workers (FSWs) in Zambian towns. In the trial, 16 interviewers were randomly assigned to respondents. We used hierarchical regression models to examine how interviewers may both affect responses on more and less sensitive topics, and confound associations between key risk factors and HIV self-test use. RESULTS: Model variance (ICC) at the interviewer level was over 15% for most topics. ICC was lower for socio-demographic and cognitively simple questions, and highest for sexual behaviour, substance use, violence and psychosocial wellbeing questions. Respondents reported significantly lower socioeconomic status and more sex-work related violence to female interviewers. Not accounting for interviewer identity in regressions predicting HIV self-test behaviour led to coefficients moving from non-significant to significant. CONCLUSIONS: We found substantial interviewer-level effects for prevalence and associational outcomes among Zambian FSWs, particularly for sensitive questions. Our findings highlight the importance of careful training and response monitoring to minimize inter-interviewer variation, of considering social distance when selecting interviewers and of evaluating whether interviewers are driving key findings in self-reported data. TRIAL REGISTRATION: clinicaltrials.gov NCT02827240 . Registered 11 July 2016.

Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective for prevention of HIV acquisition, but requires HIV testing at regular intervals. Female sex workers (FSWs) are a priority population for HIV prevention interventions in many settings, but face barriers to accessing healthcare. Here, we assessed the acceptability of HIV self-testing for regular HIV testing during PrEP implementation among FSWs participating in a randomized controlled trial of HIV self-testing delivery models. METHODS: We used data from two HIV self-testing randomized controlled trials with identical protocols in Zambia and in Uganda. From September-October 2016, participants were randomized in groups to: (1) direct delivery of an HIV self-test, (2) delivery of a coupon, exchangeable for an HIV self-test at nearby health clinics, or (3) standard HIV testing services. Participants completed assessments at baseline and 4 weeks. Participants reporting their last HIV test was negative were asked about their interest in various PrEP modalities and their HIV testing preferences. We used mixed effects logistic regression models to measure differences in outcomes across randomization arms at four weeks. RESULTS: At 4 weeks, 633 participants in Zambia and 749 participants in Uganda reported testing negative at their last HIV test. The majority of participants in both studies were "very interested" in daily oral PrEP (91% Zambia; 66% Uganda) and preferred HIV self-testing to standard testing services while on PrEP (87% Zambia; 82% Uganda). Participants in the HIV self-testing intervention arms more often reported preference for HIV self-testing compared to standard testing services to support PrEP in both Zambia (P = 0.002) and Uganda (P < 0.001). CONCLUSION: PrEP implementation programs for FSW could consider inclusion of HIV self-testing to reduce the clinic-based HIV testing burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240 and NCT02846402 .

Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites.

BACKGROUND.: Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study. METHODS.: Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. RESULTS.: MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62-0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills. CONCLUSIONS.: Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection.

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

BACKGROUND: HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. METHODS AND FINDINGS: Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. CONCLUSIONS: In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240.

Incidence of Severe and Nonsevere Pertussis Among HIV-Exposed and -Unexposed Zambian Infants Through 14 Weeks of Age: Results From the Southern Africa Mother Infant Pertussis Study (SAMIPS), a Longitudinal Birth Cohort Study.

BACKGROUND: Maternal vaccination with tetanus, reduced-dose diphtheria, and acellular pertussis vaccine (Tdap) could be an effective way of mitigating the high residual burden of infant morbidity and mortality caused by Bordetella pertussis To better inform such interventions, we conducted a burden-of-disease study to determine the incidence of severe and nonsevere pertussis among a population of Zambian infants. METHODS: Mother-infant pairs were enrolled at 1 week of life, and then seen at 2- to 3-week intervals through 14 weeks of age. At each visit, nasopharyngeal (NP) swabs were obtained from both, and symptoms were catalogued. Using polymerase chain reaction (PCR) to identify cases, and a severity scoring system to triage these into severe/nonsevere, we calculated disease incidence using person-time at risk as the denominator. RESULTS: From a population of 1981 infants, we identified 10 with clinical pertussis, for an overall incidence of 2.4 cases (95% confidence interval [CI], 1.2-4.2) per 1000 infant-months and a cumulative incidence of 5.2 cases (95% CI, 2.6-9.0) per 1000 infants. Nine of 10 cases occurred within a 3-month window (May-July 2015), with highest incidence between birth and 6 weeks of age (3.5 cases per 1000 infant-months), concentrated among infants prior to vaccination or among those who had only received 1 dose of Diphtheria Tetanus whole cell Pertussis (DTwP). Maternal human immunodeficiency virus (HIV) modestly increased the risk of infant pertussis (risk ratio, 1.8 [95% CI, .5-6.9]). Only 1 of 10 infant cases qualified as having severe pertussis. The rest presented with the mild and nonspecific symptoms of cough, coryza, and/or tachypnea. Notably, cough durations were long, exceeding 30 days in several cases, with PCRs repeatedly positive over time. CONCLUSIONS: Pertussis is circulating freely among this population of Zambian infants but rarely presents with the classical symptoms of paroxysmal cough, whooping, apnea, and cyanosis. Maternal HIV appears to increase the risk, while lack of effective exposure to DTwP increased the risk.

A clinical guidance tool to improve the care of children hospitalized with severe pneumonia in Lusaka, Zambia.

BACKGROUND: Pneumonia is the leading infectious cause of death among children, with approximately half of deaths attributable to pneumonia occurring in limited health resource settings of sub-Saharan Africa. Clinical guidance tools and checklists have been used to improve health outcomes and standardize care. This study was conducted to evaluate the impact of a clinical guidance tool designed to improve outcomes for children hospitalized with severe pneumonia in Zambia. METHODS: This study was conducted at University Teaching Hospital in Lusaka, Zambia from October 10, 2011 to March 21, 2014 among children 1 month to 5 years of age with severe pneumonia. In March 2013, a clinical guidance tool was implemented to standardize and improve care. In-hospital mortality pre-and post-implementation was compared. RESULTS: Four hundred forty-three children were enrolled in the pre-intervention period and 250 in the post-intervention period. Overall, 18.2 % of children died during hospitalization, with 44 % of deaths occurring within the first 24 h after admission. Mortality was associated with HIV infection status, pneumonia severity, and weight-for-height z-score. Despite improving and standardizing the care received, the clinical guidance tool did not significantly reduce mortality (relative risk: 0.89; 95 % CI: 0.65, 1.23). The tool appeared to be more effective among HIV-exposed but uninfected children and children younger than 6 months of age. CONCLUSIONS: Simple tools are needed to ensure that children hospitalized with pneumonia receive the best possible care in accordance with recommended guidelines. The clinical guidance tool was well-accepted and easy to use and succeeded in standardizing and improving care. Further research is needed to determine if similar interventions can improve treatment outcomes and should be implemented on a larger scale.

Verbal Autopsies for Out-of-Hospital Infant Deaths in Zambia.

OBJECTIVES: In Zambia, a significant number of infants die in the community. It is hypothesized that delays in care contribute to many of these so-called "brought in dead" infants. METHODS: We analyzed free-text narratives from verbal autopsies, in which families narrate the final series of events leading to each infant's death. Using the 3-delays model framework and working iteratively to achieve consensus, we coded each narrative using NVivo software to identify, characterize, and quantify the contribution of delays and other factors to the fatal outcome. RESULTS: Verbal autopsies were collected from 230 families of brought in dead infants younger than 6 months of age. As many as 82.8% of infants had 1 or more delays in care. The most-common delay was in the family's decision to seek care (54.8%), even as severe symptoms were frequently described. Similarly, 27.8% of infants died en route to a health care facility. Delays in receiving adequate care, including infants dying while waiting in line at a clinic or during referral from a clinic to a hospital, occurred in 24.7% of infants. A third of infants had been previously evaluated by a clinician in the days before their death. CONCLUSIONS: Delays in care were the rule rather than the exception in this population of Zambian infants. Accessing care requires families to navigate significant logistic barriers, and balance complex forces in deciding to seek care. Strategies to avoid such delays could save many infants lives.

Implementation and adherence of routine pertussis vaccination (DTP) in a low-resource urban birth cohort.

INTRODUCTION: Reliable information on rates of up-to-date coverage and timely administration of routine childhood immunisations are critical for guiding public health efforts worldwide, yet prospective observation of vaccination programmes within individual communities is rare. Here, we provide a longitudinal analysis of the directly observed administration of a three-dose primary vaccination series to infants in a low-resource community in Lusaka, Zambia. METHODS: Throughout 2015, we recruited a longitudinal birth cohort of mother/infant pairs (initial enrolment, 1981 pairs; attending, 1497 pairs) from the periurban informal settlement of Chawama compound, located in Lusaka, Zambia. We prospectively monitored the administration of scheduled diphtheria-tetanus-pertussis (DTP) vaccinations across the first 14-18 weeks of life. We analysed study attendance and vaccine coverage, both overall and stratified by age group. We employed Kaplan-Meier analyses to estimate delays in age-appropriate administration of vaccine doses. We also assessed schedule timing violations, including early and compressed dose administration. RESULTS: At study completion, first dose (DTP1) rates were high (92.9% of attending), whereas third dose completion (DTP3) rates were far lower (61.9%). Missed vaccinations and study dropout both contributed to the low DTP3 completion rates. DTP1 was administered very late (at or after 10 weeks) to 61 infants (4.1%). DTP1 was administered too early to 64 infants (4.3%), and 77 (5.1%) received consecutive doses below the minimum recommended spacing of 28 days. CONCLUSIONS: We observe substantial individual variation in the timing of early childhood DTP doses, though following this birth cohort proved challenging. Our results indicate that timely administration of both DTP1 and DTP3 remains a challenge in this community. These directly-observed, individual-based results provide an important counterpoint to more course-grained, survey-based national and province estimates of up-to-date vaccine coverage. This study also highlights the challenges of vaccine hesitancy and suboptimal utilisation of (no-cost) healthcare services in a low-resource urban setting.

Perceived Knowledge of HIV-Negative Status Increases Condom Use Among Female Sex Workers in Zambian Transit Towns.

Knowledge of HIV status is a necessary pre-condition for most HIV interventions, including treatment as well as biomedical and behavioral prevention interventions. We used data from a female sex worker (FSW) cohort in three Zambian transit towns to understand the effect that knowledge of HIV status has on FSWs' HIV risk-related sexual behaviors with clients. The cohort was formed from an HIV self-testing trial that followed participants for 4 months. Participants completed three rounds of data collection at baseline, 1 month, and 4 months where they reported their perceived knowledge of HIV status, number of clients on an average working night, and consistent condom use with clients. We measured the effect of knowledge of HIV status on participants' sexual behaviors by using linear regression models with individual fixed effects. The majority of the 965 participants tested for HIV at least once during the observation period (96%) and changed their knowledge of HIV status (79%). Knowledge of HIV status did not affect participants' number of clients, but it did affect their consistency of condom use. Compared with unknown HIV status, knowledge of HIV-negative status significantly increased participants' consistent condom use by 8.1% points [95% confidence interval (CI): 2.7-13.4, p = 0.003] and knowledge of HIV-positive status increased participants' consistent condom use by 6.1% points (95% CI: -0.1 to 12.9, p = 0.08); however, this latter effect was not statistically significant. FSWs in Zambia engaged in safer sex with clients when they learned their HIV status. The expansion of HIV testing programs may serve as a behavioral HIV prevention measure among FSWs.

Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia.

OBJECTIVES: To assess the effect of two health system approaches to distribute HIV self-tests on the number of female sex workers' client and nonclient sexual partners. DESIGN: Cluster randomized controlled trial. METHODS: Peer educators recruited 965 participants. Peer educator-participant groups were randomized 1 : 1 : 1 to one of three arms: delivery of HIV self-tests directly from a peer educator, free facility-based delivery of HIV self-tests in exchange for coupons, or referral to standard-of-care HIV testing. Participants in all three arms completed four peer educator intervention sessions, which included counseling and condom distribution. Participants were asked the average number of client partners they had per night at baseline, 1 and 4 months, and the number of nonclient partners they had in the past 12 months (at baseline) and in the past month (at 1 month and 4 months). RESULTS: At 4 months, participants reported significantly fewer clients per night in the direct delivery arm (mean difference -0.78 clients, 95% CI -1.28 to -0.28, P = 0.002) and the coupon arm (-0.71, 95% CI -1.21 to -0.21, P = 0.005) compared with standard of care. Similarly, they reported fewer nonclient partners in the direct delivery arm (-3.19, 95% CI -5.18 to -1.21, P = 0.002) and in the coupon arm (-1.84, 95% CI -3.81 to 0.14, P = 0.07) arm compared with standard of care. CONCLUSION: Expansion of HIV self-testing may have positive behavioral effects enhancing other HIV prevention efforts among female sex workers in Zambia. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240.

Brief Report: Intimate Partner Violence and Antiretroviral Therapy Initiation Among Female Sex Workers Newly Diagnosed With HIV in Zambia: A Prospective Study.

BACKGROUND: Intimate partner violence (IPV) is common among female sex workers (FSW) globally. Here, we prospectively assessed the relationship between IPV and engagement in HIV care in a cohort of FSW who had been newly diagnosed with HIV. METHODS: Data arose from the Zambian Peer Educators for HIV Self-Testing study, a randomized controlled trial of HIV self-test distribution among FSW in 3 transit towns in Zambia. Participants were self-reported to be HIV-uninfected or unaware of their status at baseline. IPV in the previous 12 months was assessed at baseline. At 4 months, participants were asked the results of their last HIV test and those who reported testing positive were asked whether they had engaged in HIV-related care and started antiretroviral therapy (ART). RESULTS: Of 964 participants, 234 (24.3%) reported that they were living with HIV at 4 months. Of these 234 participants, 142 (60.7%) reported a history of IPV (past 12 months) at baseline and at 4 months, 152 (65.0%) reported that they were in HIV-related care, and 132 (56.7%) reported that they had initiated ART. Participants who reported IPV had significantly reduced odds of engagement in care (adjusted odds ratio = 0.48, 95% confidence interval: 0.26 to 0.91) and ART initiation (adjusted odds ratio = 0.40, 95% confidence interval: 0.22 to 0.72). CONCLUSIONS: FSW living with HIV in Zambia reported very high rates of IPV. Structural and individual interventions for violence prevention are urgently needed to better protect this population. Given the strong negative relationship between IPV and engagement in HIV-related care, such interventions could also substantially improve HIV-related health outcomes.

"When you are injected, the baby is protected:" Assessing the acceptability of a maternal Tdap vaccine based on mothers' knowledge, attitudes, and beliefs of pertussis and vaccinations in Lusaka, Zambia.

INTRODUCTION: Severe and fatal pertussis infections are concentrated among infants who are too young to be protected through routine vaccinations. Maternal Tdap (mTdap), which is now the standard of care in the US and UK, is considered to be the most effective way to address this gap in preventative care. Little is known about how pregnant women in low-resource settings might view mTdap. To inform strategies for mTdap implementation in these contexts, public health researchers sought to understand knowledge, attitudes, and beliefs toward pertussis and maternal vaccines and assess the barriers to vaccine acceptance. METHODS: We conducted focus group discussions (FGDs) among mothers who participated in a longitudinal birth cohort study at the Chawama primary health center in Lusaka, Zambia. Since SAMIPS was not a clinical trial, but instead an observational cohort study, registration on clinicaltrials.gov was not required. Trained interviewers conducted the FGDs in January 2016 using a semi-structured interview guide, exploring participants' knowledge, attitudes and beliefs toward pertussis and vaccines. We analyzed the transcripts using Nvivo v.11 software. RESULTS: Fifty mothers participated across 7 FGDs. Mothers had limited knowledge of pertussis and vaccines, yet expressed generally positive views of vaccinating themselves and their children. Participants conveyed very little vaccine hesitancy around maternal vaccinations, and discussed how they could protect their children's health. Mothers also highlighted barriers and facilitators to vaccine uptake, which included partner involvement, feelings of maternal authority over healthcare decision-making, and community rumors about Western medicine. CONCLUSION: Mothers viewed vaccinations as an important method to keep their children healthy, despite cultural myths and misconceptions about pertussis and vaccines. FGD results suggest that vaccine acceptability is high in Zambia, which is a critical factor to vaccine uptake. A strategy addressing myths and misconceptions should be prioritized if and when mTdap is introduced across low-resource settings.

Contraceptive use and unplanned pregnancy among female sex workers in Zambia.

OBJECTIVES: Access to reproductive healthcare, including contraceptive services, is an essential component of comprehensive healthcare for female sex workers (FSW). Here, we evaluated the prevalence of and factors associated with contraceptive use, unplanned pregnancy, and pregnancy termination among FSW in three transit towns in Zambia. STUDY DESIGN: Data arose from the baseline quantitative survey from a randomized controlled trial of HIV self-testing among FSW. Eligible participants were 18 years of age or older, exchanged sex for money or goods at least once in the past month, and were HIV-uninfected or status unknown without recent HIV testing (<3 months). Logistic regression models were used to assess factors associated with contraceptive use and unplanned pregnancy. RESULTS: Of 946 women eligible for this analysis, 84.1% had been pregnant at least once, and among those 61.6% had an unplanned pregnancy, and 47.7% had a terminated pregnancy. Incarceration was associated with decreased odds of dual contraception use (aOR=0.46, 95% CI 0.32-0.67) and increased odds of unplanned pregnancy (aOR=1.75, 95% CI 1.56-1.97). Condom availability at work was associated with increased odds of using condoms only for contraception (aOR=1.74, 95% CI 1.21-2.51) and decreased odds of unplanned pregnancy (aOR=0.63, 95% CI 0.61-0.64). CONCLUSIONS: FSW in this setting have large unmet reproductive health needs. Structural interventions, such as increasing condom availability in workplaces, may be useful for reducing the burden of unplanned pregnancy.

Barriers and Facilitators to HIV Testing Among Zambian Female Sex Workers in Three Transit Hubs.

Zambia has a generalized HIV epidemic, and HIV is concentrated along transit routes. Female sex workers (FSWs) are disproportionately affected by the epidemic. HIV testing is the crucial first step for engagement in HIV care and HIV prevention activities. However, to date little work has been done with FSWs in Zambia, and little is known about barriers and facilitators to HIV testing in this population. FSW peer educators were recruited through existing sex worker organizations for participation in a trial related to HIV testing among FSWs. We conducted five focus groups with FSW peer educators (N = 40) in three transit towns in Zambia (Livingstone, Chirundu, and Kapiri Mposhi) to elicit community norms related to HIV testing. Emerging themes demonstrated barriers and facilitators to HIV testing occurring at multiple levels, including individual, social network, and structural. Stigma and discrimination, including healthcare provider stigma, were a particularly salient barrier. Improving knowledge, social support, and acknowledgment of FSWs and women's role in society emerged as facilitators to testing. Interventions to improve HIV testing among FSWs in Zambia will need to address barriers and facilitators at multiple levels to be maximally effective.