The pilot answers the biology.
This work answers everything else.

What this is

A counselling protocol designed for couples in which one partner (the man) carries an intervention intended to benefit the other (the woman). The protocol must address informed consent that is genuinely dyadic, asymmetries in benefit and burden, what happens when partners disagree about participation, and how to handle disclosure of trial-related findings without weaponising them.

What we are not assuming

That existing dyadic counselling curricula from HIV-discordant couples research transfer directly. They may, partially. They may also import assumptions that do not hold for a microbiome-modifying device intervention with no immediate symptomatic benefit to the person wearing it.

Who we need

• A senior co-investigator in dyadic or couples-based health interventions, ideally with sexual health or sub-Saharan African experience.
• Behavioural scientists with expertise in informed consent in low-literacy and gender-asymmetric settings.
• Curriculum developers who have built counsellor-training programmes for community health workers in East Africa.
• Critical readers — researchers who have opposed dyadic trial designs in similar contexts and can stress-test the rationale.

What collaboration looks like

We are seeking partners now, during the pilot phase, to co-develop the dyadic counselling work package. Early involvement means shaping the framework from scratch. Collaboration results in co-authorship on the published work package and positions partners for named roles in the definitive trial preparation.

What this is

A documented, trial-integrated pathway for the identification, response, and longitudinal monitoring of intimate partner violence among enrolled couples. This includes baseline screening, protocols for what trial staff do when violence is disclosed or suspected, referral relationships with local services, staff training, and a framework for whether and when participation should be paused or withdrawn.

Why we are flagging this as critical

Any intervention that touches the sexual health of a couple in a setting with prevalent intimate partner violence carries a credible risk of inadvertently triggering or worsening it. A trial that does not have a robust, externally validated safeguarding pathway in place before first participant in is not ready to run, regardless of how compelling the biology is.

Who we need

• An IPV researcher to lead this workstream — ideally someone who has built safeguarding pathways for HIV or SRH trials in East Africa.
• Ugandan organisations with existing IPV response infrastructure (CEDOVIP, Raising Voices, UWONET, district-level GBV referral networks) — partnership, not consultation.
• Safeguarding officers who have implemented and audited similar pathways and can contribute to protocol review.
• A trauma-informed clinician advisor for staff training design.

What collaboration looks like

We are seeking this collaboration during the pilot phase. Partners co-design the safeguarding pathway from the ground up, with formal organisational agreements. The pathway is intended to be publishable as a standalone output and reusable beyond this trial.

What this is

A standing community advisory infrastructure — including, centrally, a panel of women from the Rakai catchment area whose partners would be the device-wearing participants. PPIE here is not a consultation box to tick at protocol finalisation. It includes co-design of recruitment materials, consent processes, results communication, and the framing of the device in local language and cultural context.

What we are explicitly avoiding

Token PPIE — a single workshop, an honorarium, a paragraph in the protocol. The dyadic nature of this trial demands that the women who would carry the downstream benefit or harm of the intervention have continuous, structured input from now until trial close-out.

Who we need

• A PPIE methodologist to design the structure (panel composition, decision rights, remuneration, governance).
• Ugandan community-based organisations and women’s groups with existing reach in the Rakai region.
• A medical anthropologist or qualitative researcher familiar with the study area and the genital hygiene discourse there.
• Translators and local knowledge holders to ensure trial materials are culturally legible, not just linguistically translated.

What collaboration looks like

We are seeking PPIE partners during the pilot phase to begin building the community infrastructure and consent processes that the definitive trial will require. Co-authorship on PPIE methods papers and a defined role in the definitive trial preparation.