Aids, epidemics and anthropology. Despite the quantity and quality of knowledge accumulated during the past six years of research AIDS remains a subject of global uncertainty and concern. In Africa there is a quasi-paralysis of medical staff in the public sector on the issue. More than any other illness medical research on AIDS requires am analysis of cultural and individual representations within African societies.
AbstractIntroductionEarly diagnosis is key to achieving the goal of eliminating transmission of HIV and hepatitis B and C. We assessed the uptake, acceptability and interpretability of self‐testing using a 3‐in‐1 rapid diagnostic test (RDT) in facility‐based services.MethodsStand‐alone testing services were provided free of charge to consenting individuals aged ≥15 years in five facilities in northern Thailand. Clients were invited to choose between self‐testing by fingerprick or venepuncture by a healthcare worker (HCW). In each facility, several clients could simultaneously self‐test in separate private areas using TriQuik™ (Genlantis, San Diego, CA, USA), a single immunochromatographic cassette detecting HIV‐1/2 antibody, hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCAb). An interactive program on a tablet computer was developed to collect socio‐demographic, behavioural and satisfaction data and provide information to guide the self‐test process, including video instructions, results interpretation and a picture of the cassette for immediate remote review by the HCW. When the HCW interpreted an HIV self‐test as positive, the HCW collected blood by venepuncture for immediate confirmation.ResultsBetween October 2020 and April 2022, 4119 clients presented for testing for the first time as part of the project. Of them, 3462 (84.0%) opted for self‐testing. Among self‐testers, 1801 (52.0%) were born female, the median age was 27 years (interquartile range, 22–36), 661 (19.1%) belonged to at least one key population and 2124 (61.4%) had never been tested for HIV; 3329 (99.8% of those who answered) reported being "very satisfied" or "satisfied" with the testing process. The proportions of test results interpreted as positive by self‐testers among those interpreted as positive by HCWs were 95% for HIV‐1/2 antibody, 95% for HBsAg and 78% for HCAb.ConclusionsThese proportions were higher than those observed in a previous study evaluating another 3‐in‐1 RDT for HIV, HBsAg and HCAb, possibly due to the use of video instructions instead of paper‐based instructions, lower prevalence and co‐infection rates, or lower percentages of clients with low education level. Multiplex self‐testing simplified and streamlined the service delivery process and was well accepted. HCW assistance proved to be essential in a limited number of cases.
AbstractIntroductionFrequent HIV testing of at‐risk individuals is crucial to detect and treat infections early and prevent transmissions. We assessed the effect of reminders on HIV retesting uptake.MethodsThe study was conducted within a programme involving four facilities providing free‐of‐charge HIV, syphilis and hepatitis B and C testing and counselling in northern Thailand. Individuals found HIV negative and identified at risk by counsellors were invited to participate in a three‐arm, open‐label, randomized, controlled trial comparing: (a) "No Appointment & No Reminder" (control arm); (b) "No Appointment but Reminder": short message service (SMS) sent 24 weeks after the enrolment visit to remind booking an appointment, and sent again one week later if no appointment was booked; and (c) "Appointment & Reminder": appointment scheduled during the enrolment visit and SMS sent one week before appointment to ask for confirmation; if no response: single call made within one business day. The primary endpoint was a HIV retest within seven months after the enrolment visit. The cost of each reminder strategy was calculated as the sum of the following costs in United States dollars (USD): time spent by participants, counsellors and hotline staff; phone calls made; and SMS sent. The target sample size was 217 participants per arm (651 overall).ResultsBetween April and November 2017, 651 participants were randomized. The proportion presenting for HIV retesting within seven months was 11.2% (24/215) in the control arm, versus 19.3% (42/218) in "No Appointment but Reminder" (p = 0.023) and 36.7% (80/218) in "Appointment & Reminder" (p < 0.001). Differences in proportions compared to the control arm were respectively +8.1% (95% CI: +1.4% to +14.8%) and +25.5% (+17.9% to +33.2%). The incremental cost‐effectiveness ratios of "No Appointment but Reminder" and "Appointment & Reminder" compared to the control arm were respectively USD 0.05 and USD 0.14 per participant for each 5% increase in HIV retesting uptake within seven months.ConclusionsScheduling an appointment and sending a reminder one week before was a simple, easy‐to‐implement and affordable intervention that significantly increased HIV retesting uptake in these at‐risk individuals. The personal phone call to clients probably contributed, and also improved service efficiency.
BACKGROUND: In the Lao People's Democratic Republic (Lao PDR), cervical cancer is the third leading cause of women cancer. AIMS: The objective of this cross‐sectional study was to compare the efficacy of careHPV™ test versus conventional Pap smear or Siriraj liquid‐based cytology in the detection of cervical cancer in women living with human immunodeficiency virus type 1 (HIV‐1). MATERIALS & METHODS: Overall, 631 women consented to participate. Four cervical specimens were taken for the purpose of conventional Pap smear, Siriraj liquid‐based cytology, careHPV™ test, and HPV‐16 genotyping. The exact McNemar test was used to compare the efficacy and diagnostic performance of the tests. RESULTS: Of the 631 women with follow‐up, 331 were human papillomavirus (HPV) negative. High‐grade squamous intraepithelial lesions were found in 37 women, biopsy‐proven high‐grade cervical intraepithelial neoplasia in 50 women, and invasive carcinoma in seven women. The proportion of women with high‐grade cervical lesion or carcinoma detected after abnormal careHPV™ test was higher (6.02%; 95% confidence interval [CI]: 4.4–8.1) than that detected by conventional Pap smear (4.59%; 95% CI: 3.2–6.5). careHPV™ and HPV‐16 genotyping had, respectively, the highest sensitivity (80.8%; 95% CI: 67.4–89.5) and specificity (92.2%; 95% CI: 89.8–94.2). HPV‐16 was the most frequently detected genotype. CONCLUSIONS: careHPV™ test represents a screening option in Lao PDR, particularly in women living with HIV‐1 because of higher prevalence of chronic HPV in this population.
AbstractIntroductionPregnant women are routinely excluded from clinical trials, leading to the absence or delay in even the most basic pharmacokinetic (PK) information needed for dosing in pregnancy. When available, pregnancy PK studies use a small sample size, resulting in limited safety information. We discuss key study design elements that may enhance the timely availability of pregnancy data, including the role and timing of randomized controlled trials (RCTs) to evaluate pregnancy safety; efficacy and safety outcome measures; stand‐alone protocols, platform trials, single arm studies, sample size and the effect that follow‐up time during gestation has on analysis interpretations; and observational studies.DiscussionPregnancy PK should be studied during drug development, after dosing in non‐pregnant persons is established (unless non‐clinical or other data raise pregnancy concerns). RCTs should evaluate the safety during pregnancy of priority new HIV agents that are likely to be used by large numbers of females of childbearing age. Key endpoints for pregnancy safety studies include birth outcomes (prematurity, small for gestational age and stillbirth) and neonatal death, with traditional adverse events and infant growth also measured (congenital anomalies are best studied through surveillance). We recommend that viral efficacy be studied as a secondary endpoint of pregnancy RCTs, once PK studies confirm adequate drug exposure in pregnancy. RCTs typically use a stand‐alone protocol for new agents. In contrast, master protocols using a platform design can add agents over time, possibly speeding safety data ascertainment. To speed accrual, stand‐alone pregnancy trial protocols can include pre‐specified starting rules based upon adequate PK levels in pregnancy; and seamless master protocols or platform trials can include a pregnancy PK and safety component. When RCTs are unethical or cost‐prohibitive, observational studies should be conducted, preferably using target trial emulation to avoid bias.ConclusionsPregnancy PK needs to be obtained earlier in drug evaluation. Timely RCTs are needed to understand safety in pregnancy for high‐priority new HIV agents. RCTs that enrol pregnant women should focus on outcomes unique to pregnancy, and observational studies should focus on questions that RCTs are not equipped to answer.
