We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.

This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.

Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.

MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.

Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays

Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I² and pooled estimates calculated with 95% CIs using the Wilson (score) method.

Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I², 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.

Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.

IS 2024 CRD42024558385.

Sexual and gender-based violence can have long-term impacts on the physical and mental health of survivors, with demonstrated impairments to immune, endocrine and nervous systems, and increased risk of chronic conditions such as cardiovascular disease, depression and post-traumatic stress. Moreover, survivors commonly experience low self-efficacy and lack of perceived control over their lives. Creating space for survivors to feel empowered through a multidimensional approach to health promotion, considering both physical and psychological influences on health, is necessary to reduce chronic disease.

In this type II hybrid effectiveness-implementation cluster randomised controlled trial, we evaluate a novel peer-led intervention that combines expressive writing and trauma-informed boxing, Left Write Hook, against trauma-informed boxing alone—an intervention approach that is currently accessible in the community and has been shown to improve both mental and physical health. 20 clusters of 8–10 adults (n=150) with a self-reported history of child sexual abuse or other gender-based violence will be recruited in Melbourne, Australia, through health services and the community. Clusters will be randomly assigned to complete either 8x weekly group sessions of Left Write Hook (intervention) involving both expressive writing and trauma-informed boxing led by a trained peer facilitator, or 8x weekly group boxing sessions led by a trauma-informed boxing facilitator (control). Implementation will be evaluated against the PRISM Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. The primary effectiveness outcome is change in self-efficacy from preintervention to postintervention (8 weeks). Secondary effectiveness outcomes are changes in symptoms of complex post-traumatic stress disorder, trauma-related cognition and indicators of physical fitness (strength, flexibility, aerobic fitness and balance). Assessment will be completed online or over the phone with a member of the research team at preintervention (0 weeks), postintervention (8 weeks) and at 1 month following completion of the intervention (12 weeks). The primary implementation outcome is the fidelity of the train-the-champion implementation strategy for intervention training and delivery, and the secondary implementation outcome is adoption of the intervention and training delivery.

Ethical approval was received from the Human Research Ethics Committee of The University of Melbourne (2024-28998-60131-11) and the Alfred Hospital Ethics Committee (110810). Results will be disseminated via publication in a peer-reviewed journal, and data will be made available via Open Science Framework at the conclusion of the trial.

ACTRN12624000862549.

Doxycycline postexposure prophylaxis (doxy-PEP) can prevent sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender women (TGW). STI rates are high among MSM and TGW in China, and implementation strategies are needed to optimise doxy-PEP services. Pay-it-forward and social network distribution approaches may increase uptake of STI services and could increase the uptake of doxy-PEP. We present the protocol for a randomised controlled trial evaluating the effectiveness of pay-it-forward strategies with and without adjunctive social network distribution among MSM and TGW in China.

A total of 399 MSM and TGW will be recruited at seven sites in China and randomly allocated in a 1:1:1 ratio to (1) self-pay, (2) pay-it-forward alone or (3) pay-it-forward with adjunctive social network distribution of doxy-PEP. Participants assigned to the self-pay arm can purchase a doxy-PEP packet out-of-pocket. Participants in the pay-it-forward arm will be offered a free doxy-PEP packet and the opportunity to donate to support doxy-PEP for future participants. Participants in the pay-it-forward arm with social network distribution will receive the pay-it-forward intervention as well as additional free doxy-PEP packets to distribute to peers. Those randomised to the self-pay and the pay-it-forward with social network distribution arms (ie, index participants) will receive and distribute referral cards to recruit additional peers (ie, alter participants). Alter participants recruited through the control arm will be referred to the clinic to purchase doxy-PEP. Alter participants recruited through the pay-it-forward with adjunctive social network distribution arm will receive doxy-PEP directly from referring index participants. Both index and alter participants in each arm will be asked to complete a follow-up survey 3 and 6 months after enrolment. The primary outcome will be the proportion of participants who report using doxy-PEP within 72-hours of condomless anal or oral sex on one or more occasions during follow-up.

Ethical approval was obtained from the ethics review committee of the Dermatology Hospital of Southern Medical University (Approval number: 2023109). The findings will be disseminated in peer-reviewed publications.

The study has been registered with the Chinese Clinical Trial Registry (trial ID ChiCTR2300074903). Date of registration: 18 August 2023.