An interventional study of TENDAI4PrEP and Enhanced treatment as usual in HIV Infections, Pregnancy Related and Depression, Anxiety, sponsored by Massachusetts General Hospital. Recruiting at 1 site in Zimbabwe. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
Among 26 studies in HIV Infections by Massachusetts General Hospital — 4 open to participants now, 5 under way, none of them phase 3. HIV Infections · Massachusetts General Hospital.
Among the 26 studies in HIV Infections by Massachusetts General Hospital, this one is the 6th largest by planned enrollment of the 19 interventional ones, is one of 3 that started in 2024, is one of 15 with no phase, and was the 26th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 165 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →4 of the 26 studies in HIV Infections by Massachusetts General Hospital are open now, in 3 countries. Each count lists the studies.
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 15 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2024.
Median enrollment 60 across the 19 interventional studies, 120 across the 7 observational. Of the 21 that completed or were terminated, 9 (43%) have results posted.
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
3 of the studies in HIV Infections by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06226155Massachusetts General HospitalAdaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe | 2027-01-01 |
| NCT05842161Massachusetts General HospitalSouth Africa Smoking Cessation and Engagement in HIV/TB Care Care | 2027-05-01 |
| NCT05373758Massachusetts General HospitalA Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa | 2027-06-30 |
Among the 26 studies in HIV Infections by Massachusetts General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.
Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmission during pregnancy, there is an urgent public health need to develop interventions that increase the use of efficacious HIV prevention strategies like PrEP in the antenatal context. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care (ANC) clinics. However, PrEP use remains low among cisgender women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, stigma, low partner support, limited PrEP knowledge in providers) compromise use.
A multi-level, problem-solving intervention that addresses barriers to PrEP adherence and persistence during pregnancy and through the postpartum transition among patients, their partners, and antenatal care providers could improve the health of pregnant persons, ultimately decreasing HIV incidence in Zimbabwe.
The aims of this study are as follows:
Aim 1: Explore the impact of intersecting, multi-level barriers on PrEP uptake, adherence, and persistence during pregnancy (n=30), and explore barriers to PrEP provision among antenatal care providers (8-10). In individual interviews with HIV-negative pregnant women with psychological distress (15 PrEP naïve, 15 PrEP experienced), the investigators will probe individual, interpersonal/community, and structural barriers/facilitators. It is anticipated that barriers to uptake, adherence, and persistence may include distress linked to common mental health challenges (e.g., depressed mood, posttraumatic stress) at the individual level; lack of support from partners and providers, stigma, and low PrEP awareness at the interpersonal/community level; and limited access to PrEP care and food insecurity/poverty at the structural level. Among providers, interviews will explore PrEP knowledge, perspectives on HIV prevention during pregnancy, and barriers to prescribing PrEP.
Aim 2: Specify the manual and conduct a small proof-of-concept trial with patients (n=5), their partners (n=5), and providers (n=2). The new manual will teach skills to navigate resources and problem solve the multi-level barriers to PrEP use identified in Aim 1 and will include a group-based training for all providers (education on PrEP during pregnancy, negative PrEP attitudes/stigma, and other barriers to prescribing). Content of the manual will be interactively refined on five participants, their partners, and two providers.
Aim 3a: Evaluate the feasibility and acceptability of the patient-level intervention in a pilot RCT (n=70). PrEP eligible pregnant persons with motivation to initiate PrEP who are experiencing psychological distress will be randomized to either the intervention or to enhanced treatment as usual (mental health referral). Primary outcomes will be feasibility and acceptability; it is hypothesized that the intervention (4 sessions, including one dyadic session with a partner (n \~ 35), plus a postpartum booster) will be both feasible and acceptable. Secondary outcomes are self-reported PrEP adherence and psychological distress at the end of treatment as well as PrEP persistence (measured via urine) at 3-month follow-up. Though the study is not powered to detect secondary outcome effects, we anticipate clinically meaningful trends. Aim 3b: Evaluate the feasibility and acceptability of the provider training (1 session), which will be offered to all providers (n\~10) in a nonrandomized pre/post design; it is hypothesized that the training will be feasible and acceptable. Aim 3c: Explore perceptions of key implementation outcomes among providers and other administrators (n \~ 25) through individual qualitative exit interviews. In individual qualitative exit interviews, we will explore reach, adoptability, and other key components of the RE-AIM framework to inform future implementation in the clinic. All providers and staff who completed the group-based session will be invited to participate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Across all aims participants must be
Score >5 on the Shona Symptom Questionnaire
For the RCT, eligible participants must also be willing to
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy.
Behavioral: TENDAI4PrEP
Participants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy/postpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital.
Other: Enhanced treatment as usual
An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy. safety during pregnancy/postpartum, and PrEP availability at the ANC.
Feasibility (patient level)
Assessed by (1) 75% of the participants attended at least half of all treatment sessions (2) 80% of the reviewed treatment sessions addressed all key themes, and (3) 60% of the participants completed the assessments at T2 and T3.
Time frame: T3 (within 5 months post-baseline)
Acceptability (patient level)
Assessed via the brief health care interventions framework questionnaire; on average, at least 75% of the participants rate four or more of the items on the postsession acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
Time frame: T3 (within 5 months post-baseline)
Feasibility (provider level)
Feasibility will be demonstrated if (1) at least 70% of the antenatal clinic providers attend the group sessions and (2) a review of the audio recording indicates that all key themes were addressed.
Time frame: T3 (within 5 months post-baseline)
Acceptability (provider level)
Assessed via the brief health care interventions framework questionnaire; the sessions will be deemed acceptable if, on average, at least 75% of the providers rate four or more of the items on the post-session acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
Time frame: T3 (within 5 months post-baseline)
Self-reported PrEP adherence (patient level)
Assessed at T2 via an adapted version of the Wilson three-item self-report adherence scale.This is a 0-100 scale with 0 representing the lowest possible adherence and 100 representing the highest adherence.
Time frame: T2 (2 months post-baseline)
Psychological distress (patient level)
Measured by the Shona Symptom Questionnaire. Scores from 0-14, with a higher score indicating greater psychological distress.
Time frame: T2 (2 months post-baseline)
PrEP persistence (patient level)
PrEP persistence will be determined via urine tests and defined as tenofovir being detected in a validated point-of-care device with a level of detection of at least 1500 nanograms \[ng\] TFV/milliliter \[mL\], indicative of taking a dose of PrEP within the past 24 hours. The test is sensitive (96%), specific (100%), precise (coefficient of variation \<15%), and quantitates tenofovir levels in urine as accurately as LC-MS/MS (correlation between TFV levels by both assays 0.96) in a study of HIV negative patients taking PrEP with TDF/FTC. This threshold may be adjusted pending new data; pregnancy appears to alter the pharmacokinetics of oral PrEP such that differences in TVF-DP levels may be as great as 30-40% between pregnant and postpartum women.
Time frame: T3 (within 5 months post-baseline)
Change in PrEP knowledge (provider level)
Will be assessed in a PrEP-Related Knowledge Scale adapted from the Fenway Institute. Total scores may range from 0-8 with higher scores indicating greater PrEP knowledge. PrEP knowledge will be assessed at baseline and 5 months post-baseline to determine change in knowledge after the intervention.
Time frame: Baseline, T3 (within 5 months post-baseline)
Change in PrEP stigma (provider level)
Will be assessed via an adapted version of the Community PrEP-Related Stigma Scale. Each item is measured on a 1-5 Likert Scale. Scores range from 16-80, with higher scores indicating greater stigma. PrEP stigma will be assessed at baseline and 5 months post-baseline to determine change in stigma after the intervention.
Time frame: Baseline, T3 (within 5 months post-baseline)
Plan to share: Yes — In accordance with our DMS plan, de-identified data will be deposited to NIMH Data Archive. This will be available to the research community free of charge. In addition to individual level data, the following materials and tools will be made available to interested individuals following achievement of the main aims of the project: qualitative interview guides, qualitative codebooks, and the TENDAI4PrEP intervention manual.
Supporting information: Study protocol, Statistical analysis plan
Time frame: NDA will make decisions about how long to preserve the data; however, NDA has not deleted any deposited data as to date. Data will be deposited every 6 months.
Access criteria: Those accessing this dataset must register through NDA and agree to the Terms of Use. Users must agree to not re-disseminate data, use appropriate data citation, and to maintain human subjects' protections. The standard NDA data process allows access for one year and is renewable.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jan 2027, 26 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 26 months is close to that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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