Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa

Introduction
Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa.

Methods and analysis
We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (

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Dicembre 2022

Characteristics of HIV pre-exposure prophylaxis users at first PrEP counselling visit: the CSL-PrEP cohort

Objectives
Pre-exposure prophylaxis (PrEP) is effective for HIV prevention and is mostly used by men who have sex with men (MSM). The aim of this study was to describe the characteristics of a cohort of PrEP users at first PrEP counselling visits (baseline, BL).

Design
Cross-sectional study of a cohort of MSM receiving PrEP (Centro San Luigi, CSL-PrEP Cohort).

Setting
Secondary-level sexually transmitted infections (STI) centre in Milan, Italy, from May 2017 to May 2022.

Participants
Overall, 624 MSM PrEP users were included; most users were Caucasian (97%), attended university (64%), with a median BL age of 34.5 years.

Results
Overall, 45% choose the daily-based PrEP regimen, 55% the event-based one. An increasing trend in PrEP counselling visits was observed (p=0.024). The majority had between 10 and 19 partners in the 3 months before BL and 41% were chemsex users. All had a HIV Incidence Risk Index for MSM (HIRI-MSM) >10, 54% between 20 and 29. Overall, 50% had ≥1 previous STI and 22% ≥1 BL STI. BL chlamydia (10%) was often more frequent than in the past (7%). The number of sexual partners was associated with BL chlamydia (p

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Dicembre 2022

Consent Laws for Minors Regarding Sexually Transmitted Infection and HIV Services

To the Editor The recent Research Letter about minor consent laws underscored a critical but poorly understood medicolegal concept: informed consent to medical treatment does not automatically confer confidentiality on the health information that is subsequently generated. State laws that empower minors to provide independent consent typically do so based on either an adolescent’s legal status or the type of health care service involved. The latter category tends to involve sensitive matters such as sexually transmitted infection (STI), HIV, pregnancy, sexual assault, substance misuse, or mental health conditions in which family emotions may already be strained and patient concerns over privacy especially heightened.

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Dicembre 2022

Consent Laws for Minors Regarding Sexually Transmitted Infection and HIV Services—Reply

In Reply State laws that enable minors to consent independently to health care have important limitations, including those raised by Mr Kels. Minor consent regimes are complex and often require simultaneous application of multiple statutes, which makes the laws difficult to interpret and trust. Although these laws address the barrier of guardian consent for minors who are unable or unwilling to involve their guardian, they fail to address other hurdles that may reduce minors’ access to care. To seek care independently, minors depend on clinicians to decide that they have both the mental and legal capacity to make medical decisions without their guardians’ permission. Often, the laws also require clinicians to make a threshold judgment about whether the type of care qualifies for minors’ independent consent (eg, awaiting guardian permission would pose a threat to health). These determinations may be challenging for clinicians who are uncertain about the content of the laws or who fear that the laws will not protect them in the event of lawsuits. As Kels emphasizes, most consent laws also give clinicians separate discretion in whether to keep minors’ health information confidential from their guardians. Minors do not control these decisions; they depend on clinicians to act for their benefit.

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Dicembre 2022