Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial

INTRODUCTION : Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. METHODS : ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. RESULTS : PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit. CONCLUSIONS : There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme.https://onlinelibrary.wiley.com/journal/17582652am2020Family Medicin

Sexually transmitted infections among women randomised to depot medroxyprogesterone acetate, a copper intrauterine device or a levonorgestrel implant

OBJECTIVES : Reproductive aged women are at risk of pregnancy and sexually transmitted infections (STI). Understanding drivers of STI acquisition, including any association with widely used contraceptives, could help us to reduce STI prevalence and comorbidities. We compared the risk of STI among women randomised to three contraceptive methods. METHODS : We conducted a secondary analysis to assess the risk of chlamydia and gonorrhoea in a clinical trial evaluating HIV risk among 7829 women aged 16–35 randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) or a levonorgestrel (LNG) implant. We estimated chlamydia and gonorrhoea prevalences by contraceptive group and prevalence ratios (PR) using log-binomial regression. RESULTS : At baseline, chlamydia and gonorrhoea prevalences were 18% and 5%, respectively. Final visit chlamydia prevalence did not differ significantly between DMPA-IM and copper IUD groups or between copper IUD and LNG implant groups. The DMPA-IM group had significantly lower risk of chlamydia compared with the LNG implant group (PR 0.83, 95% CI 0.72 to 0.95). Final visit gonorrhoea prevalence differed significantly only between the DMPA-IM and the copper IUD groups (PR 0.67, 95% CI 0.52 to 0.87). CONCLUSIONS : The findings suggest that chlamydia and gonorrhoea risk may vary with contraceptive method use. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use.http://sti.bmj.comhj2021Family Medicin

Reliability and validity of the Four Square Step Test in patients with hip osteoarthritis before and after total hip replacement

Objective To determine the validity and inter- and intra-rater reliability of the Four Square Step Test (FSST) in assessing gait performance, balance and physical function for patients with hip osteoarthritis before and after total hip replacement (THR). Design Observational, repeated measures. Setting A specialist orthopaedic hospital. Participants Fifty-eight participants with moderate to severe hip osteoarthritis scheduled to receive primary hip replacement within 4 months from recruitment. Main outcome measure Time to complete the FSST, time and steps to complete the Figure of 8 Walk Test (F8W) and Berg Balance Scale score (BBS). Results The Bland and Altman limits of agreement for intra-rater measurements of the FSST were −3.2 s to 3.5 seconds before THR and −1.5 to 2.0 seconds after THR. Limits of agreement for two different raters were −2.2 to 3.4 seconds, all with small mean differences indicating little bias between raters or replications. Concurrent validity was assessed, and the FSST correlated highly with the F8W (r = 0.7, P &lt; 0.001) and moderately with the BBS (r = 0.6, P &lt; 0.001). Only one participant was rated as being at moderate risk of falls on the BBS, with the other participants scoring low; only one participant failed to complete the F8W. This is in contrast to the FSST, which 21 people failed to complete pre-operatively. Conclusions The FSST is a valid and reliable measure of multi-directional stepping speed and balance, giving a more informative measure of gait performance than the F8W and BBS, and is feasible for use in a clinical population of patients both before and after THR.</p

Reliability and validity of the Four Square Step Test in patients with hip osteoarthritis before and after total hip replacement

Objective To determine the validity and inter- and intra-rater reliability of the Four Square Step Test (FSST) in assessing gait performance, balance and physical function for patients with hip osteoarthritis before and after total hip replacement (THR). Design Observational, repeated measures. Setting A specialist orthopaedic hospital. Participants Fifty-eight participants with moderate to severe hip osteoarthritis scheduled to receive primary hip replacement within 4 months from recruitment. Main outcome measure Time to complete the FSST, time and steps to complete the Figure of 8 Walk Test (F8W) and Berg Balance Scale score (BBS). Results The Bland and Altman limits of agreement for intra-rater measurements of the FSST were −3.2 s to 3.5 seconds before THR and −1.5 to 2.0 seconds after THR. Limits of agreement for two different raters were −2.2 to 3.4 seconds, all with small mean differences indicating little bias between raters or replications. Concurrent validity was assessed, and the FSST correlated highly with the F8W (r = 0.7, P Conclusions The FSST is a valid and reliable measure of multi-directional stepping speed and balance, giving a more informative measure of gait performance than the F8W and BBS, and is feasible for use in a clinical population of patients both before and after THR.</p

Development of a functional rehabilitation intervention for post knee arthroplasty patients: COmmunity based Rehabilitation post Knee Arthroplasty (CORKA) trial

Knee osteoarthritis is a common cause of disability in older people and knee arthroplasty surgery in the UK is increasing. The CORKA trial is a randomised controlled trial of rehabilitation targeted at patients identified as being at risk of a poor outcome after knee arthroplasty. This paper describes the development and delivery of the CORKA intervention. It was informed by current evidence, relevant guidelines, expert and patient opinion, practical considerations and a pilot study. The intervention is a multicomponent rehabilitation programme with the main component being an exercise programme delivered to participants in their own home. It includes functional task practice, strategies to improve adherence and where appropriate the provision of appropriate aids and equipment

The reliability and validity of the Figure of 8 Walk test in older people with knee replacement: does the setting have an impact?

Objective To determine the reliability and validity of the Figure of 8 Walk test (F8W) for older people after knee replacement surgery in the home setting. Design Observational repeated measures. Setting A specialist orthopaedic hospital and participants homes. Participants Seventy-four older adults aged over 55 years one year following knee replacement surgery participated in two assessments more than one week apart. Main Outcome Measure The time to complete, steps, boundary limits and smoothness score from the Figure of 8 Walk test (F8W), the time to complete the Timed Up and Go (TUG) test and the time to complete the Timed Walk Test (TWT). Results Overall, on 95% of occasions, the difference between the measurements for intra-rater reliability were within 1.8 second of the two test times. The difference between the measurements for inter-rater reliability were found to be narrower than for intra-rater reliability with scores within 1.2 second overall on 95% of occasions. The time to perform the F8W was highly correlated to the Timed Up and Go (overall sample r = 0.921) and the variability spread within narrow limits (−0.8 to 0.8 z-scores). This was also true for the Timed Walk Test (overall sample r = 0.834) with a narrow limit of variability on almost all of the observations (−1.16 to 1.16 z-scores). Conclusions The F8W test has good reliability and validity when used in either a clinical or home setting for patients around one year following knee replacement surgery.</p

The reliability and validity of the Figure of 8 Walk test in older people with knee replacement: does the setting have an impact?

Objective To determine the reliability and validity of the Figure of 8 Walk test (F8W) for older people after knee replacement surgery in the home setting. Design Observational repeated measures. Setting A specialist orthopaedic hospital and participants homes. Participants Seventy-four older adults aged over 55 years one year following knee replacement surgery participated in two assessments more than one week apart. Main Outcome Measure The time to complete, steps, boundary limits and smoothness score from the Figure of 8 Walk test (F8W), the time to complete the Timed Up and Go (TUG) test and the time to complete the Timed Walk Test (TWT). Results Overall, on 95% of occasions, the difference between the measurements for intra-rater reliability were within 1.8 second of the two test times. The difference between the measurements for inter-rater reliability were found to be narrower than for intra-rater reliability with scores within 1.2 second overall on 95% of occasions. The time to perform the F8W was highly correlated to the Timed Up and Go (overall sample r = 0.921) and the variability spread within narrow limits (−0.8 to 0.8 z-scores). This was also true for the Timed Walk Test (overall sample r = 0.834) with a narrow limit of variability on almost all of the observations (−1.16 to 1.16 z-scores). Conclusions The F8W test has good reliability and validity when used in either a clinical or home setting for patients around one year following knee replacement surgery.</p