PEP prevents HIV after an exposure, but it does not prevent other sexually transmitted infections (STIs), since the medications used in PEP are antiretrovirals, drugs which are specifically acting against HIV.  

However, Doxy PEP (Doxycycline post-exposure prophylaxis) has recently become available. Doxy PEP is a short, preventative course of Doxycycline antibiotics you can take to prevent chlamydia, gonorrhea, and syphilis after an exposure. Doxy PEP involves taking 200 mg (one or two pills) of doxycycline, a common antibiotic. Doxy PEP must be taken within 24-72 hours of an exposure, and it is more effective the sooner you take it. For more information, visit this resource from the San Francisco AIDS Foundation or this resource from the San Francisco City Clinic.

It is safe and effective to take Doxy PEP alongside PEP, PrEP, and emergency contraception.

It is possible to transition directly from PEP to PrEP! You do not need to take a break between the two. If you think it’s likely that you’ll have another HIV exposure, it’s better to avoid a gap between PEP and PrEP. As soon as you’re done with PEP, your healthcare provider can give you an HIV test and then get you started with PrEP immediately.

PEP (post-exposure prophylaxis) is a medication you can take after an HIV exposure to prevent HIV infection. You have to start PEP within 72 hours of exposure, and it is more effective the sooner you start to take it. After you start PEP, you will need to take it daily for 28 days. PEP is available in the emergency room in a crisis, but it’s also possible to get it from an urgent care, your primary care, or a sexual health clinic.

PrEP is effective for preventing HIV when taken before an exposure. If you have already had an exposure, PEP (post-exposure prophylaxis) may be a good option. See the next question below for more information about PEP.

What we do know:

• For receptive anal sex, you will have maximum protection after 7 days of daily oral PrEP.

• For receptive frontal/vaginal sex, the CDC says you will have maximum protection after 21 days of daily oral PrEP.

• For injection drug use, the CDC says you will have maximum protection after 21 days of daily oral PrEP.

What we don’t know:

• When insertive partner will have maximum protection during anal or frontal/vaginal sex

• When you will have maximum protection from injectable PrEP

Dr. Kenneth Mayer suggests that although the time to optimal protection from injectable PrEP is not well understood, if you decide to start injectable PrEP, it makes sense to follow the guidelines for when you would be protected by daily oral PrEP for the best possible estimate.

For more information on how long it takes to have maximum protection from PrEP, read these guidelines from the CDC.

There are various options when it comes to PrEP forms. Here is a quick flowchart that can guide your decision-making process when it comes to which PrEP works for you.

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There is currently one kind of injectable PrEP available, which is called Apretude (cabotegravir)^TM. It is an intramuscular injection, which your healthcare provider will administer every two months after an initial loading dose.  

Injectable PrEP is approved for anyone who needs protection from HIV during sex. However, injectable PrEP is currently not recommended for people who need protection from HIV during injection drug use or while sharing injection supplies.

If it has been less than 12 hours when you realize you missed a dose of PrEP, take your missed dose right away. Past 12 hours, wait until it is time to take your next dose as usual.  

PrEP is less effective when you miss doses (much like birth control). If you miss just one pill very occasionally, you should still have a high level of protection. If you’ve missed more doses, let your healthcare provider know, and consider using another form of protection from HIV (such as condoms) until you’ve reached maximum protection again. Data suggests that 4 or more pills a week still has a high level of protection for anal sex, while anything less than 6 a week is significantly less protection for frontal/vaginal sex.

Truvada^TM (tenofovir disoproxil fumarate and emtricitabine) has been approved for people of all genders, so Truvada is a safe and reliable choice no matter what types of sex or HIV exposures you have.

Descovy^TM (tenofovir alafenarmide and emtricitabine) is currently only approved for cisgender men and transfeminine people because there hasn’t been adequate research evaluating whether it’s effective for cisgender women or transmasculine people. There is currently an ongoing study of Descovy^TM in cisgender women, so we should have more information in the future. Dr. Kenneth Mayer suggests that Descovy^TM is most likely an effective option if your only HIV exposure is through anal sex, but if there is any potential for an HIV exposure through frontal /vaginal sex, Descovy^TM is not yet known to be effective and may not be the best option available for you.  

Some people use on-demand PrEP instead of daily PrEP. This means that they take 2 pills 2 to 24 hours before a possible HIV exposure, 1 pill 24 hours after the first dose, and 1 pill 24 hours after the second dose.

The 2-1-1 method has only been tested in cisgender men using PrEP to prevent HIV transmission during anal sex. At this point, it’s not possible to definitively say whether it’s effective in other groups of people, including transmasculine people, or for different types of exposures, such as vaginal sex or sharing injection supplies.  

The primary concern is that PrEP may take longer to be fully effective in cervical and vaginal tissues than rectal tissue. Some analyses of daily PrEP suggest that rectal tissues, cervical and vaginal tissues have different pharmacology in regards how quickly the medicine (tenofovir) gets into each tissue type. Missed doses of medication may be less problematic for people whose only exposure to HIV is through anal sex, because of tenofovir’s rapid uptake in anal cells, compared to cervical and vaginal cells. That means that when you use a method that involves taking fewer doses, or if you miss doses, you may be less protected from HIV during frontal/vaginal exposures than anal exposures.  

Since we know that daily oral PrEP and injectable PrEP are effective for transmasculine people, those are the most reliable options until we have more information.

You will need HIV testing every three months while you are on PrEP. Even though it’s very unlikely that you will get HIV if you are taking PrEP as prescribed, it’s important to test regularly because taking PrEP medication if you become HIV positive can result in drug resistance to the antiretroviral medications used to treat HIV.

If it is difficult for you to see your healthcare provider regularly, there are many online options for HIV testing. There are also a number of telehealth services available online that prescribe oral PrEP. For more information, see our resource list.  

Most insurance plans and state Medicaid plans cover PrEP. Co-payments and deductibles may vary state by state, but many clinics and the companies that make PrEP have programs to subsidize those costs of PrEP for those with more limited means. If you are uninsured, there are other programs available to help pay for PrEP. Look at this flowchart and this list of PrEP financial assistance programs.

If taken as prescribed, PrEP is highly effective at protecting you from HIV during condomless sex. However, PrEP does not protect you from other kinds of STIs or prevent pregnancy. Whether it makes sense to stop using condoms or other barriers depends on your specific situation, and whether might be at risk of other STIs or unwanted pregnancy.

PrEP is only effective for preventing HIV. It does not prevent other STIs. When taking PrEP and having condomless sex, it is good practice to see a provider quarterly for routine STI screening, since many STI are asymptomatic.

It is safe and effective to be on both PrEP and HRT.

It is safe and effective to take both PrEP and birth control or emergency contraception.

There are no known interactions between PrEP and alcohol or any recreational drugs.

PrEP can cause some people to experience side effects including nausea, diarrhea, headaches, fatigue, and stomach pain. Typically these side effects go away within a few days.

PrEP (pre-exposure prophylaxis) is a preventative antiviral medication that if taken appropriately reduces your chances of getting HIV if you are exposed. It is available either as an oral medication or as an injection. When PrEP is taken as prescribed, it is a highly effective way of preventing HIV transmission (99% effective for exposures through sex, and at least 74% effective for exposures through injection drug use).

Doxycycline is generally inexpensive and covered by health insurance.

You should still get tested for chlamydia, gonorrhea, syphilis, and HIV every 3 to 6 months.  DoxyPEP is not 100% effective. If you test positive for an STI while you are on DoxyPEP, you will still need treatment for it.

Yes, it is safe and effective to take DoxyPEP and PrEP at the same time.

The likelihood of DoxyPEP reducing the effectiveness of hormonal contraceptives is generally considered low. Doxycycline does not typically interfere with most hormonal birth control methods, such as pills, patches, or injections. If a patient is on oral contraception, some clinicians might ask that they take the DoxyPEP at a different time, but mostly to avoid upsetting the stomach.

In general, we have not seen worsening antibiotic resistance with DoxyPEP to the point where it has been clinically significant. However, we are still monitoring for that, since we don’t have long term data. Read this article for more information about antibiotic resistance.

Common side effects may include nausea and gastrointestinal upset. Taking doxycycline with food may help with this. Some people may also be more sensitive to sunlight while taking doxycycline, so using sunscreen and minimizing sun exposure is recommended. Frequent use of broad-spectrum antibiotics may be associated with frontal/vaginal yeast infections, although this was not seen in the trial of DoxyPEP in cisgender women. Talk to your doctor about any concerns you have before starting DoxyPEP, and reach out to them if you experience side effects.  

There are no specific risks of using DoxyPEP for STI prevention while having vaginal/frontal sex.

You need a prescription to take DoxyPEP. You may be able to get a prescription from your primary care provider, gender-affirming hormones provider, or a sexual health clinic. Clinics that specialize in LGBTQ+ health may be the most likely to be knowledgeable about DoxyPEP. You can also get DoxyPEP from some online telehealth services, like MISTR,Freddie, Wisp, and Q Care Plus.

Take 200mg of doxycycline within 3 days (72 hours) of a sexual encounter. The sooner you take it, the more effective it is. It’s safe to take DoxyPEP daily, but never take it more than once a day. Taking it with food may reduce the likelihood of side effects such as nausea.

Currently, the CDC recommends DoxyPEP for cisgender men and transgender women who have sex with men.  We don’t have much data right now on whether it is effective for people who were assigned a female sex at birth (AFAB) and have vaginal/frontal sex. One study has indicated that it may not be effective for preventing chlamydia, gonorrhea, and syphilis during vaginal/frontal sex, but there were very low rates of adherence (taking the medication) during that trial. That means that right now, it's hard to know if DoxyPEP truly doesn't work for AFAB people who have frontal/vaginal sex, or whether that study didn't show that it was effective because of the low adherence.  

Until we know whether low rates of medication adherence explained the lack of effectiveness in that trial, we cannot be sure that the medication is as protective for individuals engaging in frontal/vaginal sex as it is for individuals engaging in anal sex. There is no reason to think that DoxyPEP protection for individuals engaging in anal sex is different between people who were assigned a male sex at birth and AFAB people. Other studies are currently underway to see if DoxyPEP works for people who have frontal/vaginal sex.

At Fenway Health, we take an informed consent approach. If an AFAB patient is aware that we currently don’t have great effectiveness data around the use of DoxyPEP for AFAB people, we allow them to make the best decisions for themselves. We also make sure that they are not pregnant or chestfeeding because those are safety concerns.  

Different clinics and healthcare providers may take different approaches. While some clinics may also take an informed consent approach, others may only prescribe DoxyPEP to cisgender men and transgender women.

Doxycycline post-exposure prophylaxis (DoxyPEP) is when a person takes the antibiotic doxycycline (doxy) after sex to reduce their chance of getting chlamydia, gonorrhea, and syphilis. Chlamydia, gonorrhea, and syphilis can be transmitted during oral, frontal/vaginal, and anal sex. DoxyPEP does not prevent other STIs, such as HIV or Mpox.

You will be paid for your participation in this research study. We will pay you:

• $30 each time you complete a full-length survey at baseline, 3, 6, 12, and 18 months.  

• $10 each time you complete a short survey at 9 months and 15 months.

• $20 for each HIV test kit you complete and return.  

• $10 for each intervention session (virtual peer navigation and/or virtual peer support group) you attend.  

• $50 if you are selected for an interview and you choose to participate.

Depending on what group you are randomly assigned to, you may be asked to complete no intervention sessions, 6 intervention sessions, or 12 intervention sessions. If you are asked to repeat the baseline survey and home test kit, you will be paid again. You may or may not be asked to participate the 9-month interview. You will not be paid for the optional intervention sessions in months 12-18 of the study.

You will receive payment in the form of a pre-paid gift card called ClinCard. You will receive the physical card in the mail at your preferred address. Your payment will be loaded onto the card shortly after each of your visits. We will pay you using the same card throughout the entire study, so we suggest keeping it in a safe location. If your card is lost, stolen, or damaged please contact one of the study staff members and we will mail you another card. Any balance you had on the original card will automatically transfer to the new card. However, we cannot replace money that was spent on a lost or stolen card.

Participation in the study can last up to 18 months (about 1.5 years). Below is a summary of the study activities. All study activities will be done online digitally through a platform like Zoom. All sample collections (HIV testing) will be done from your home.

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Study activities include:

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Online survey (about 30 minutes):  

We will ask you to complete an online survey. The survey will ask questions about your background, health, sex life, mood, stressors, attitudes, alcohol/drug use, and other experiences. It will include questions about experiences of discrimination or mistreatment. You will complete online surveys at your first visit (baseline) and 3, 6, 12, and 18 months. Though all the same topics will be covered, the baseline and 6-month surveys will be slightly different. In the first survey, we will want to see what information you may already know before one of the interventions. In the 6-month survey, we will ask about your experiences with the intervention you were assigned to. These surveys will be sent to you by email.

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Short online survey (approximately 15 minutes):  

We will ask you to complete a short survey to monitor PrEP use. You will complete these surveys at months 9 and 15. These will be sent to you through your preferred method of contact.

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Blood sample collection (about 15 minutes):  

You will receive a discrete blood sample collection kit in the mail from Molecular Testing Labs (MTL), using the name and mailing address that you provide. You should receive the kit through the US Postal Service within 2-3 days of the order being placed by study staff. Your first (baseline) kit should be returned within 1 week of the delivery date. Additionally, all samples should be shipped to the lab within 5 days of collection to make sure the sample is testable. We encourage you to mail your kit the same day you complete it.

The kit includes:

• Materials and instructions to prick your finger and collect drops of your blood on a storage card.
• A pre-paid envelope for free return shipping to the lab.  

Once you collect your sample, you will mail the card to the laboratory in the pre-paid envelope. You can return the sealed package to any mailbox or a post office location near you. After you mail your kit, the lab will receive it within 2-3 days. The lab will screen all returned samples for HIV and test for the level of PrEP in your blood. All of the materials you send to MTL and the results they release will be identified by your study ID number or a kit ID number. Your name will only be on the mailing materials, not on the lab report.

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HIV results delivery:  

Each blood collection kit you complete will be tested for HIV. Results are typically returned within 2 weeks (14 days). When your results are ready, study staff will contact you at your preferred phone number. The kit will also be tested for PrEP medication (presence of the medication in your blood). The PrEP levels testing process is different and does not generate results to deliver.

A note about this kind of HIV testing: If the sample tests positive for HIV antigens and antibodies, it does not mean you have been diagnosed with HIV. Another test is needed to confirm that result. Should this occur, study staff will help connect you to testing services near you. Once connected, you will schedule the additional test with the testing site. Based on those results, your healthcare team will help you plan for any needed care. The clinic or other testing site is required to report a positive result to your state health department. They do this so that public health officials can monitor what’s happening with the HIV epidemic in your city and state. Many states and some cities have partner-notification laws. These laws require someone who tests positive for HIV (or their healthcare provider) to tell their sex or needle-sharing partner(s). A positive HIV diagnosis ends your study participation, but we will keep your study data that we have already collected.  

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Intervention:  

You will be randomly assigned to 1 of 4 study groups. Intervention activities range from none to 3.5 hours per week for 6 weeks, depending on the study group you are assigned to. These activities may include one-on-one peer navigation, group discussions, both, or neither. Everyone will also have access to a website with information about HIV services and PrEP.

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Study Schedule:

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First (baseline) study visit (total time 45 minutes):

• Online survey – must be completed within 1 week of visit
• Blood sample collection – must be completed within 1 week of delivery date and within 5 days of collection date

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HIV test results and randomization (total time 20 minutes):

• When we deliver your HIV test result and you are confirmed to be HIV-negative, we will randomly assign you to one of the 4 study groups. You will be assigned by chance (like the flip of a coin, or the drawing of a lottery). We do not have any control over which group you are assigned to.  
• As a reminder, the groups are:
  • Group A (total time varies): Access to a website with information about HIV services and PrEP. You will have the option of reviewing the provided materials as often as you want.
  • Group B (9 hours over 6 weeks): One-on-one peer support and access to the website. There will be one (1) one-on-one peer session that lasts 90 minutes once a week for 6 weeks.  
  • Group C (12 hours over 6 weeks): Small group-based support and access to the website. There will be one (1) small-group peer session that lasts 2 hours once a week for 6 weeks. You may have to wait for a group to form. If your group hasn’t begun before your 6-month follow-up, you will be asked to complete a new baseline survey and DBS kit. If this happens, you will be compensated for your second baseline survey and home test kit.
  • Group D (18 hours over 6-12 weeks): One-on-one peer support, small group-based support, and a website with information about HIV services and PrEP. You will be asked to complete all of the sessions described for Groups B and C. You may have to wait for a group to form so you may not participate in both interventions at the same time.

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Month 3 and 18 (total time 45 minutes):

• Online survey

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Months 6 and 12 (total time 45 minutes each):

• Online survey
• Blood sample collection  

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Months 9 and 15 (total time 15 minutes each):

• Short online survey

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Month 9 interview (total time 1-1.5 hours):  

• We plan to ask some participants to complete an interview. Interview selection will not be random, but instead based on certain study characteristics. We will select both participants who are taking PrEP and participants who aren’t taking PrEP from each study group.
• During the interview, we will ask questions about the materials you were given and your thoughts on HIV prevention and PrEP use. The interview will take place online. The audio will be recorded and transcribed using Zoom’s automated audio transcription feature so that the study staff can remember what is said.  
• Not everyone who participates in the study will be asked to interview.

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Months 12-18 optional peer and small-group sessions (total time varies):

• After you complete your study assigned group strategy, you can choose to take part in one-on-one peer navigation sessions, small-group sessions, or both. This is so that you can have a chance to learn and experience the same things as other participants in the study. These sessions will cover the same material and take the same amount of time as described above.  

• You do not need to take part in these optional sessions to take part in the study. These optional sessions are not compensated.

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Missed Activities:

• You will be asked to complete online surveys every 3-6 months while in the study. If necessary, you may complete a survey up to 3 months before or 3 months after the due date for your next follow-up. This excludes the baseline survey, which may be completed up to 1 week after the due date.  
• You will be asked to complete blood sample collection kits three times while in the study. If necessary, you may complete a blood sample collection kit up to 3 months after the due date.
• You may be assigned to participate in small-group sessions. If you cannot attend a session, you will receive a summary sheet summarizing the missed session. The summary will be sent through your preferred contact method.

If you are interested in participating, study staff will check whether you live in an EHE priority hotspot when you complete the screener to check eligibility.  

If you would like to check ahead of time, you can consult the CDC’s list of EHE priority hotspots here.

To participate in the TOGETHR study, you must meet the following requirements:

• Are 18 years or older.

• Are a man, transgender man, or transmasculine (ex. nonbinary, genderqueer, genderfluid, etc.) and assigned a female sex at birth.  

• Are sexually active with one or more partners who have a penis and were assigned a male sex at birth.

• Have access to a smartphone or computer with internet access.

• Are HIV-negative.

• Have had certain kinds of sex, shared injection supplies, and/or been diagnosed with a sexually transmitted infection in the last 3 months.

• Live in an Ending the HIV Epidemic (EHE) priority hotspot.  

• Are comfortable reading and conversing in English.

The transgender community is well represented in the TOGETHR study staff, with trans researchers working in various roles on the team, including as staff and three of the study investigators. The TOGETHR study also has a Community Advisory Board (CAB) of community members who use their lived experience to provide ongoing guidance and feedback to the project.

The purpose of the study is to learn more about how effective different peer-to-peer strategies are at preventing HIV and supporting pre-exposure prophylaxis (PrEP) access in transgender men and transmasculine people. PrEP is a prescription medication that reduces the risk of acquiring HIV.

We will use what we learn from this study to create better tools to help support the sexual health and well-being of transgender men and transmasculine people.